15.11.2024
To the attention of interested persons
Updated advice to minimise risks of interaction between weight loss medicine Mysimba and opioids
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14.11.2024
To the attention of interested persons
Leqembi recommended for treatment of early Alzheimer’s disease
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18.10.2024
To the attention of interested persons
Translarna: EMA re-confirms non-renewal of authorisation of Duchenne muscular dystrophy medicine
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04.10.2024
To the attention of interested persons
EMA starts safety review of medicines containing finasteride and dutasteride
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20.09.2024
To the attention of interested persons
EMA recommends measures to minimise serious outcomes of known side effect with painkiller metamizole
download document …

06.09.2024
To the attention of interested persons
EMA recommends measures to minimise serious outcomes of known side effect with painkiller metamizole
download document …

26.07.2024
To the attention of interested persons
EMA advises about risks of using weight loss medicine Mysimba with opioids
download document …

24.07.2024
To the attention of interested persons
EMA confirms its recommendation to update the antigenic composition of authorised COVID-19 vaccines for 2024-2025
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12.07.2024
To the attention of interested persons
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 July 2024
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28.06.2024
To the attention of interested persons
Hydroxyprogesterone caproate medicines to be suspended from the EU market
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28.06.2024
To the attention of interested persons
EMA recommends revoking conditional marketing authorisation for Ocaliva
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28.06.2024
To the attention of interested persons
EMA recommends non-renewal of authorisation of Duchenne muscular dystrophy medicine Translarna
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26.06.2024
To the attention of interested persons
EU actions to tackle shortages of GLP-1 receptor agonists
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14.06.2024
To the attention of interested persons
Review of painkiller metamizole started
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12.06.2024
To the attention of interested persons
Recommendations of the Executive Steering Group on Shortages and Safety of Medicinal Products on shortage of Glucagon-Like Peptide-1 (GLP-1) receptor agonists
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16.05.2024
To the attention of interested persons
Hydroxyprogesterone caproate medicines to be suspended from the EU market.
Medicinal products containing 17-hydroxyprogesterone caproate (17-OHPC) are not authorised for marketing in Romania.
download document …

12.04.2024
To the attention of interested persons
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 April 2024: GLP-1 receptor agonists: available evidence not supporting link with suicidal and self-injurious thoughts and actions
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22.03.2024
To the attention of interested persons
Synapse Labs Pvt. Ltd: re-examination confirms suspension of medicines over flawed studies
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12.03.2024
To the attention of interested persons
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 March 2024
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12.01.2024
To the attention of interested persons
Potential risk of neurodevelopmental disorders in children born to men treated with valproate medicines: PRAC recommends precautionary measures
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12.12.2023
To the attention of interested persons
First version of the Union list of critical medicines agreed to help avoid potential shortages in the EU
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12.12.2023
To the attention of interested persons
Questions and answers on the Union list of critical medicines
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01.12.2023
To the attention of interested persons
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27-30 November 2023
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31.10.2023
To the attention of interested persons
EMA recommends approval of adapted Nuvaxovid COVID-19 vaccine targeting Omicron XBB.1.5
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18.10.2023
To the attention of interested persons
EMA alerts EU patients and healthcare professionals to reports of falsified Ozempic pens
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06.10.2023
To the attention of interested persons
Revised transparency rules for the EU Clinical Trials Information System (CTIS)
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26.09.2023
To the attention of interested persons
The Ministry of Health and the National Agency for Medicines and Medical Devices of Romania (NAMMDR) continue to carry out controls at the premises of units authorised to perform activities concerning narcotic and psychotropic medicinal products.
Collaboration with the competent institutions in carrying out the investigation related to the suspicion of crimes of trafficking or illicit consumption of narcotic medicinal products is a priority of the Ministry of Health and its subordinated institutions.
As early as September the 18th this year, NAMMDR inspectors began assessing compliance with the legality of the release of medicinal products containing oxycodone and fentanyl. The inspectors have thus identified more than 500 pharmaceutical units (pharmacies) that carry out operations with these medicinal products. These shall all be inspected over the next period.
The checks will also aim at the supervision and control of the fulfilment of legal procedures regarding the return and destruction of narcotic and psychotropic medicinal products which no longer correspond from a quality viewpoint, whose shelf life has expired or coming from patients who no longer use them.
Moreover, the Ministry of Health, according to the yearly inspection plan, has started inspection actions, prior to the investigation in question and which will continue over the following period. The subject of these inspections shall be expanded, in order to ensure that all stages of the destruction process provided by law are observed.
In the immediate future, the Ministry of Health, together with the NAMMDR and other institutions involved in this field, shall initiate a project to amend the regulatory documents in force, with a view to much stricter regulations regarding activities related to psychotropic and narcotic medicinal products.

14.09.2023
To the attention of interested persons
Spikevax: EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5
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01.09.2023
To the attention of interested persons
PRAC recommends new measures to avoid topiramate exposure in pregnancy
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30.08.2023
To the attention of interested persons
Comirnaty: EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5
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16.08.2023
To the attention of interested persons
EMA review of data on paternal exposure to valproate
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21.07.2023
To the attention of interested persons
Start of a review concerning the conduct of studies at Synapse Labs Pvt. Ltd, India
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19.07.2023
To the attention of interested persons
Reflection paper on the use of artificial intelligence in the lifecycle of medicines
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11.07.2023
To the attention of interested persons
EMA statement on ongoing review of GLP-1 receptor agonists
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27.06.2023
To the attention of interested persons
Withdrawal of application for the marketing authorisation of Lagevrio (molnupiravir)
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23.06.2023
To the attention of interested persons
Refusal of the marketing authorisation for Albrioza (sodium phenylbutyrate / ursodoxicoltaurine)
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26.05.2023
To the attention of interested persons
EMA recommends revocation of authorisation for sickle cell disease medicine Adakveo
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12.05.2023
To the attention of interested persons
Fluoroquinolone antibiotics: reminder of measures to reduce the risk of long-lasting, disabling and potentially irreversible side effects
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12.05.2023
To the attention of interested persons
Review of hydroxyprogesterone started.
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30.03.2023
To the attention of interested persons
EMA recommends approval of Bimervax as a COVID-19 booster vaccine.
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10.02.2023
To the attention of interested persons
PRAC starts safety review of pseudoephedrine-containing medicines
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27.01.2023
To the attention of interested persons
Review of sickle cell disease medicine Adakveo started
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27.01.2023
To the attention of interested persons
EMA confirms measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders
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13.01.2023
To the attention of interested persons
Withdrawal of marketing authorisations for amfepramone medicines within the EU.
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13.01.2023
To the attention of interested persons
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9 – 12 January 2023
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16.12.2022
To the attention of interested persons
EMA recommends withdrawal of pholcodine medicines from EU market
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06.12.2022
To the attention of interested persons
ETF concludes that bivalent original/Omicron BA.4-5 mRNA vaccines may be used for primary vaccination
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06.12.2022
To the attention of interested persons
ETF statement on the use of the EMA approved bivalent original/Omicron BA.4-5 mRNA vaccines for primary series
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02.12.2022
To the attention of interested persons
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 November – 1 December 2022
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02.12.2022
To the attention of interested persons
EMA recommends withdrawal of pholcodine medicines from EU market
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30.11.2022
To the attention of interested persons
Status update: Implementation of the Clinical Trials Regulation
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11.11.2022
To the attention of interested persons
EMA confirms measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders
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11.11.2022
To the attention of interested persons
EMA confirms recommendation to withdraw marketing authorisations for amfepramone medicines
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10.11.2022
To the attention of interested persons
EMA recommends approval of VidPrevtyn Beta as a COVID 19 booster vaccine
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28.10.2022
To the attention of interested persons
EMA recommends measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders
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28.10.2022
To the attention of interested persons
EMA confirms recommendation to withdraw marketing authorisations for amfepramone medicines
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30.09.2022
To the attention of interested persons
New recommendations for terlipressin-containing medicines in the treatment of hepatorenal syndrome
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12.09.2022
To the attention of interested persons
Adapted vaccine targeting BA.4 and BA.5 Omicron variants and original SARS-CoV-2 recommended for approval
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02.09.2022
To the attention of interested persons
PRAC starts review of topiramate use in pregnancy and women of childbearing potential
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02.09.2022
To the attention of interested persons
Review of pholcodine medicines started
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07.03.2022
To the attention of interested persons
New measures to minimise risk of meningioma with medicines containing nomegestrol or chlormadinone
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03.08.2022
To the attention of interested persons
COVID-19 vaccines safety update
descarcă documentul …

12.07.2022
To the attention of interested persons
Updated joint statement from ECDC and EMA on additional booster doses of COVID-19 vaccines
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08.07.2022
To the attention of interested persons
Medicines containing nomegestrol or chlormadinone: PRAC recommends new measures to minimise risk of meningioma
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10.06.2022
To the attention of interested persons
EMA recommends withdrawal of marketing authorisation for amfepramone medicines
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06.05.2022
To the attention of interested persons
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 May 2022
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12.04.2022
To the attention of interested persons
THE NAMMDR encourages the reporting of adverse effects of medicines for human use and vaccines by citizens coming from Ukraine to Romania, through healthcare professionals
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08.04.2022
To the attention of interested persons
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4 – 7 April 2022
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07.03.2022
To the attention of interested persons
ECDC and EMA issue advice on fourth doses of mRNA COVID-19 vaccines
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07.03.2022
To the attention of interested persons
COVID-19: Joint statement from ECDC and EMA on the administration of a fourth dose of mRNA vaccines
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11.03.2022
To the attention of interested persons
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 March 2022
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02.03.2022
To the attention of interested persons
Starting with Tuesday, 1 March 2022, Mr. Răzvan Mihai Prisada is the new president of the National Agency for Medicines and Medical Devices of Romania, following promotion of the competition organised by the Ministry of Health for filling the vacant management position for an indefinite period.
Răzvan Mihai Prisada is a pharmacist and a Doctor of Pharmacy and has occupied the position of Vice President of the Romanian College of Pharmacists since 2016.
In 2019, having extensive experience in the pharmaceutical field and in national and European medicinal product policies, Răzvan Mihai Prisada coordinated, as chair, the activity of the Working Group on Pharmaceuticals and Medical Devices within the Council of the European Union.
“This is a time when the Agency, through its essential role in the Romanian healthcare system and at European level, together with the other national agencies, must ensure efficient management of medicinal products and medical devices on the Romanian market. Particularly in the context of the global crisis we are all experiencing, patients’ right to access to appropriate medical treatment is mandatory, and healthcare institutions must assess the risks and find effective solutions as soon as possible. There are many things that need to be put back on a normal track, so that the institution regains its prestige and its specialists are valued once again”, says Răzvan Mihai Prisada, the new president of the NAMMDR.

01.03.2022
To the attention of interested persons
Regulation on EMA’s extended mandate becomes applicable
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24.02.2022
To the attention of interested persons
EMA recommends approval of Spikevax for children aged 6 to 11
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28.01.2022
To the attention of interested persons
Start of a review concerning the conduct of studies at Synchron Research Services, India
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27.01.2022
To the attention of interested persons
COVID-19: EMA recommends conditional marketing authorisation for Paxlovid
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14.01.2022
To the attention of interested persons
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10 – 13 January 2022
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11.01.2022
To the attention of interested persons
Preliminary data indicate COVID-19 vaccines remain effective against severe disease and hospitalisation caused by the Omicron variant
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10.01.2022
To the attention of interested persons
EMA receives application for conditional marketing authorisation for Paxlovid (PF-07321332 and ritonavir) for treating patients with COVID-19
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17.12.2021
To the attention of interested persons
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 December 2021
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20.12.2021
To the attention of interested persons
Nuvaxovid – COVID-19 Vaccine (recombinant, adjuvanted)
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16.12.2021
To the attention of interested persons
EMA recommends approval for use of Kineret in adults with COVID-19
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13.12.2021
To the attention of interested persons
Health Technology Assessment: Commission welcomes the adoption of new rules to improve access to innovative technologies
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07.12.2021
To the attention of interested persons
EMA and ECDC recommendations on heterologous vaccination courses against COVID-19
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06.12.2021
To the attention of interested persons
EMA recommends approval for use of RoActemra in adults with severe COVID-19
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03.12.2021
To the attention of interested persons
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 November – 2 December 2021.
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25.11.2021
To the attention of interested persons
Comirnaty COVID-19 vaccine: EMA recommends approval for children aged 5 to 11
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23.11.2021
To the attention of interested persons
EMA receives application for marketing authorisation for Lagevrio (molnupiravir) for treating patients with COVID-19
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22.11.2021
To the attention of interested persons
EMA evaluating data on booster dose of COVID-19 Vaccine Janssen
download document …

19.11.2021
To the attention of interested persons
EMA starts review of Paxlovid for treating patients with COVID-19
download document …

18.11.2021
To the attention of interested persons
EMA receives application for marketing authorisation for Xevudy (sotrovimab) for treating patients with COVID-19
download document …

17.11.2021
To the attention of interested persons
EMA receives application for conditional marketing authorisation of Novavax’s COVID-19 vaccine, Nuvaxovid
download document …

10.11.2021
To the attention of interested persons
EMA starts evaluating use of COVID-19 vaccine Spikevax in children aged 6 to 11
download document …

08.11.2021
To the attention of interested persons
COVID-19: EMA and Heads of Medicines Agencies update on molnupiravir; EMA starts review to support possible national decisions on early use
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02.11.2021
To the attention of interested persons
EMA ends rolling review of the antibodies bamlanivimab and etesevimab for COVID-19 following withdrawal by Lilly
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02.11.2021
To the attention of interested persons
Questions and answers on end of rolling review for antibodies bamlanivimab and etesevimab for COVID-19.
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29.10.2021
To the attention of interested persons
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 October 2021
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25.10.2021
To the attention of interested persons
Spikevax: EMA recommendation on booster
download document …

25.10.2021
To the attention of interested persons
COVID-19: EMA starts rolling review of molnupiravir
download document …

12.10.2021
To the attention of interested persons
Questions and answers on end of rolling review for CureVac’s COVID-19 vaccine (CVnCoV)
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14.10.2021
To the attention of interested persons
EMA starts rolling review of Evusheld (tixagevimab and cilgavimab)
download document …

12.10.2021
To the attention of interested persons
EMA ends rolling review of CVnCoV COVID-19 vaccine following withdrawal by CureVac AG
download document …

11.10.2021
To the attention of interested persons
EMA receives application for marketing authorisation for Ronapreve (casirivimab / imdevimab) for treatment and prevention of COVID-19
download document …

07.10.2021
To the attention of interested persons
Additional manufacturing site for COVID-19 Vaccine Janssen
download document …

04.10.2021
To the attention of interested persons
Comirnaty and Spikevax: EMA recommendations on extra doses and boosters
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04.10.2021
To the attention of interested persons
EMA receives application for marketing authorisation for Regkirona (regdanvimab) for treating patients with COVID-19
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01.10.2021
To the attention of interested persons
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27-30 September 2021
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01.10.2021
To the attention of interested persons
EMA starts review of meningioma risk with nomegestrol- and chlormadinone-containing medicines
download document …

27.09.2021
To the attention of interested persons
EMA evaluating data on booster dose of COVID-19 vaccine Spikevax
download document …

09.09.2021
To the attention of interested persons
Increase in manufacturing capacity for COVID-19 vaccine from BioNTech/Pfizer
download document …

06.09.2021
To the attention of interested persons
EMA evaluating data on booster dose of COVID-19 vaccine Comirnaty.
download document …

03.09.2021
To the attention of interested persons
Shortage of RoActemra (tocilizumab)
download document …

02.09.2021
To the attention of interested persons
ECDC and EMA highlight considerations for additional and booster doses of COVID-19 vaccines
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24.08.2021
To the attention of interested persons
Increase in vaccine manufacturing capacity for COVID-19 vaccines from BioNTech / Pfizer and Moderna
download document …

06.08.2021
To the attention of interested persons
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5 August 2021
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04.08.2021
To the attention of interested persons
ECDC and EMA update on COVID-19: Full vaccination is key to protecting against serious COVID-19, including disease caused by the Delta variant
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23.07.2021
To the attention of interested persons
COVID-19 vaccine Spikevax approved for children aged 12 to 17 in EU
download document …

22.07.2021
To the attention of interested persons
COVID-19 Vaccine Janssen: Guillain-Barré syndrome listed as a very rare side effect
download document …

20.07.2021
To the attention of interested persons
EMA starts rolling review of COVID-19 vaccine Vidprevtyn
download document …

19.07.2021
To the attention of interested persons
EMA starts evaluating the use of Kineret in adult COVID-19 patients at increased risk of severe respiratory failure
download document …

09.07.2021
To the attention of interested persons
EMA finds no evidence linking viral vector in Zynteglo to blood cancer.
download document …

09.07.2021
To the attention of interested persons
EMA advises against use of COVID-19 Vaccine Janssen in people with history of capillary leak syndrome.
download document …

09.07.2021
To the attention of interested persons
Comirnaty and Spikevax: possible link to very rare cases of myocarditis and pericarditis.
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11.06.2021
To the attention of interested persons
COVID-19 Vaccine Janssen: authorities in EU take steps to safeguard vaccine quality
download document …

11.06.2021
To the attention of interested persons
COVID-19 vaccines: update on ongoing evaluation of myocarditis and pericarditis.
download document …

11.06.2021
To the attention of interested persons
Vaxzevria: EMA advises against use in people with history of capillary leak syndrome
download document …

08.06.2021
To the attention of interested persons
EMA evaluating the use of COVID-19 Vaccine Moderna in young people aged 12 to 17
download document …

07.06.2021
To the attention of interested persons
EMA raises awareness of clinical care recommendations to manage suspected thrombosis with thrombocytopenia syndrome.
download document …

01.06.2021
To the attention of interested persons
Additional manufacturing capacity for BioNTech/Pfizer’s COVID-19 vaccine.
download document …

28.05.2021
To the attention of interested persons
First COVID-19 vaccine approved for children aged 12 to 15 in EU.
download document …

27.05.2021
To the attention of interested persons
Insufficient data on use of inhaled corticosteroids to treat COVID-19
download document …

21.05.2021
To the attention of interested persons
EMA issues advice on use of sotrovimab (VIR-7831) for treating COVID-19.
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21.05.2021
To the attention of interested persons
Vaxzevria: further advice on blood clots and low blood platelets.
download document …

07.05.2021
To the attention of interested persons
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 May 2021.
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07.05.2021
To the attention of interested persons
EMA starts rolling review of sotrovimab (VIR-7831) for COVID-19.
download document …

04.05.2021
To the attention of interested persons
EMA starts evaluating use of Olumiant in hospitalised COVID-19 patients requiring supplemental oxygen.
download document …

28.04.2021
To the attention of interested persons
AstraZeneca’s COVID-19 vaccine: benefits and risks in context.
download document …

28.04.2021
To the attention of interested persons
Annex to Vaxzevria Art.5.3 – Visual risk contextualisation.
download document …

21.04.2021
To the attention of interested persons
COVID-19 Vaccine Janssen: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets:
EMA confirms overall benefit-risk remains positive.
download document …

15.04.2021
To the attention of interested persons
COVID-19 Vaccine Janssen: assessment of very rare cases of unusual blood clots with low platelets continues.
download document …

15.04.2021
To the attention of interested persons
AstraZeneca’s COVID-19 vaccine: EMA to provide further context on risk of very rare blood clots with low blood platelets.
download document …

09.04.2021
To the attention of interested persons
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 April 2021
download document …

07.04.2021
To the attention of interested persons
AstraZeneca’s COVID-19 vaccine: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets
download document …

31.03.2021
To the attention of interested persons
AstraZeneca COVID-19 vaccine: review of very rare cases of unusual blood clots continues
download document …

25.03.2021
To the attention of interested persons
EMA press release: COVID-19 Vaccine AstraZeneca – Update on ongoing evaluation of blood clot cases
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22.03.2021
To the attention of interested persons
EMA press release: EMA advises against use of ivermectin for the prevention or treatment of COVID-19 outside randomised clinical trials.
download document …

18.03.2021
To the attention of interested persons
EMA press release: COVID-19 Vaccine AstraZeneca: benefits still outweigh the risks despite possible link to rare blood clots with low blood platelets
download document …

15.03.2021
To the attention of interested persons
EMA press release: Review of thalassaemia medicine Zynteglo started.
download document …

15.03.2021
To the attention of interested persons
EMA press release: EMA’s safety committee continues investigation of COVID-19 Vaccine AstraZeneca and thromboembolic events – further update
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11.03.2021
To the attention of interested persons
EMA press release: EMA recommends COVID-19 Vaccine Janssen for authorisation in the EU.
download document …

11.03.2021
To the attention of interested persons
EMA press release: COVID-19 Vaccine Janssen (COVID-19 vaccine (Ad26.COV2-S [recombinant])).
download document …

11.03.2021
To the attention of interested persons
EMA press release: EMA starts rolling review of Eli Lilly antibodies bamlanivimab and etesemivab for COVID-19.
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11.03.2021
To the attention of interested persons
EMA press release: COVID-19 Vaccine AstraZeneca: PRAC preliminary view suggests no specific issue with batch used in Austria (ABV5300) – Batch number ABV5300 of COVID-19 Vaccine AstraZeneca has not been distributed in Romania.
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11.03.2021
To the attention of interested persons
EMA press release: Reflection paper on the regulatory requirements for vaccines intended to provide protection against variant strain(s) of SARS-CoV-2.
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04.03.2021
To the attention of interested persons
EMA press release: EMA review of regdanvimab for COVID-19 to support national decisions on early use
download document …

08.03.2021
To the attention of interested persons
EMA press release: EMA issues advice on use of antibody combination (bamlanivimab / etesevimab)
download document …

04.03.2021
To the attention of interested persons
EMA press release: EMA starts rolling review of the Sputnik V COVID-19 vaccine
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04.03.2021
To the attention of interested persons
The NAMMDR took note of the existence in the public space of some statements announcing the intention to conduct a clinical study in Romania in order to investigate the efficacy of ivermectin in preventing and treating the Sars-CoV-2 infection.
The NAMMDR states that, so far, no application has been submitted for authorisation of a clinical trial for investigation of ivermectin.
Please note that, in Romania, according to the provisions of Article 7011 of Law no. 95/2006 on healthcare reform, republished, as amended, the NAMMDR authorises and controls clinical trials with medicinal products for human use by assessing compliance with good practices in clinical trials with or without therapeutic benefit, as well as the clinical trial site.
Thus, clinical trials are conducted in compliance with the principles and detailed guidelines on good clinical practice, the Rules on the implementation of good clinical practice rules conducted with medicinal products for human use approved by Order of the Minister of Health no. 904/2006 for approval of Norms relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use and Scientific Council Decision no.2 / 22.04.2014 on approval of Regulations for authorisation of sites for conduct of clinical trials on medicinal products for human use – as amended through Scientific Council Decision no. 24/03.07.2015.

03.03.2021
To the attention of interested persons
EMA press release: Adapting COVID-19 vaccines to SARS-CoV-2 variants: guidance for vaccine manufacturers
download document …

23.02.2021
To the attention of interested persons
EMA press release: EMA starts evaluating use of Veklury in COVID-19 patients not requiring supplemental oxygen
download document …

23.02.2021
To the attention of interested persons
EMA press release: Precautionary marketing suspension of thalassaemia medicine Zynteglo
download document …

18.02.2021
To the attention of interested persons
EMA press release: EMA receives application for conditional marketing authorisation of COVID-19 Vaccine Janssen
download document …

16.02.2021
To the attention of interested persons
EMA press release: Review of amfepramone medicines started
download document …

12.02.2021
To the attention of interested persons
EMA press release: EMA starts rolling review of CureVac’s COVID-19 vaccine (CVnCoV)
download document …

11.02.2021
To the attention of interested persons
EMA press release: Clarification on Sputnik V vaccine in the EU approval process
download document …

08.02.2021
To the attention of interested persons
EMA press release: EMA reviewing data on monoclonal antibody use for COVID-19
download document …

08.02.2021
To the attention of interested persons
EMA press release: COVID-19 Vaccine AstraZeneca
download document …

05.02.2021
To the attention of interested persons
EMA press release: EMA recommends COVID-19 Vaccine AstraZeneca for authorisation in the EU
download document …

05.02.2021
To the attention of interested persons
EMA press release: EMA starts rolling review of Novavax’s COVID-19 vaccine (NVX-CoV2373)
download document …

02.02.2021
To the attention of interested persons
EMA press release: EMA starts rolling review of REGN-COV2 antibody combination (casirivimab / imdevimab)
download document …

02.02.2021
To the attention of interested persons
EMA press release: First COVID-19 vaccine safety update published
download document …

02.02.2021
To the attention of interested persons
EMA press release: COVID-19 vaccine safety update (COMIRNATY BioNTech Manufacturing GmbH)
download document …

01.02.2021
To the attention of interested persons
EMA press release: Clarification of Comirnaty dosage interval
download document …

29.01.2021
To the attention of interested persons
Notice on administration of ivermectin as prophylaxis and treatment in Covid-19
Following the information published in the media concerning the use of ivermectin as prophylaxis and treatment in Covid-19, the NAMMDR makes the following clarifications:
1. Ivermectin is an antiparasitic chemotherapy medicinal product, being used in the treatment of parasitic diseases in both veterinary and human medicine. It is similarly used in the treatment of parasitic skin diseases, scabies and pediculosis included.
2. In Romania, only one medicinal product for human use is approved, containing ivermectin, namely a cream administered in rosacea.
3. There are several medicinal products containing ivermectin for antiparasitic indications as well as for rosacea, available in Europe.
4. Several controlled clinical trials are currently being conducted, both in Europe and globally, including patients with COVID-19 or their contacts in order to demonstrate possible benefits in this condition. Based on in vitro studies which have shown that ivermectin has an anti-inflammatory and antiviral effect, these in vivo studies in humans have been designed and are available online at: https://clinicaltrials.gov/.
5. In the most recent protocol for treatment of the SARS-CoV-2 infection (Order of the Ministry of Health No. 2054 of 27 November 2020, published in the Official Gazette no. 1167/3 December 2020 amending the Annex to Order of the Minister of Health no. 487 / 2020), ivermectin is not mentioned as an effective mediicnal product in this disease.
Patients are thus advised not to use ivermectin outside of therapeutic indications, since no final data on its efficacy in Covid-19 is currently available.
6. So far, the NAMMDR has not received any request for assessment in order to approve the conduct of clinical trials with ivermectin in Romania.

19.01.2021
To the attention of interested persons
Appointment of a new NAMMD President
Starting today, 19 January 2021, Ms. Roxana Stroe regains the status of President of the National Agency for Medicines and Medical Devices. Ms. Roxana Stroe, MD, is a Senior Physician in Clinical Pharmacology and has been working for the NAMMD for 11 years. Since 2014, she has been a member of the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee. She has been Coordinator of the Agency’s Pharmacovigilance and Risk Management Directorate, being actively involved, together with the Agency’s and the Ministry of Health’s team, in the actions organised on the occasion of Romania’s mandate at the presidency of the Council of the European Union.
“The Covid-19 pandemic is a difficult period for all of us, but together with the Ministry of Health, the NAMMDR team of professionals will continue to promptly address the inherent challenges in the pandemic and provide fast and efficient solutions for the benefit of the Romanian patient. The Agency’s experts are an active part of the most important EMA working groups and contribute to the implementation of the European strategy for handling the crisis caused by the SARS-Cov-2 virus.”
Enlarging the team of experts, increasing the degree of transparency of activities carried out in a professional manner, contributing, together with the Ministry of Health, the National Health Insurance House (NHIH) and other relevant institutions to various projects in order to increase patients’ access to medicinal products are some of the immediate objectives of the new President, Ms. Stroe.

12.01.2021
To the attention of interested persons
EMA press release: EMA receives application for conditional marketing authorisation of COVID-19 Vaccine AstraZeneca
download document …

08.01.2021
To the attention of interested persons
EMA press release: EMA recommends COVID-19 Vaccine Moderna for authorisation in the EU
download document …

08.01.2021
To the attention of interested persons
EMA press release: COVID-19 Vaccine Moderna
download document …

06.01.2021
To the attention of interested persons
EMA press release: Update on rolling review of AstraZeneca’s COVID-19 vaccine
download document …

05.01.2021
To the attention of interested persons
EMA press release: EMA public stakeholder meeting on COVID-19
download document …
download document …

16.01.2020
To the attention of interested persons
Following the suspension by the EUROPEAN DIRECTORATE FOR THE QUALITY OF MEDICINES (EDQM) of Certificates of Suitability (CEP) to the Monographs of the European Pharmacopoeia for the active substance ranitidine hydrochloride, resulting from detection of nitrosamine impurities (NDMA), the National Agency for Medicines and Medical Devices of Romania (ANMDMR) has requested the barring from sale at pharmacy level of pharmaceutical forms for both oral administration and solution for injection of ranitidine containing medicinal products. This is a precautionary measure pending the European Commission decision on ranitidine containing medicines affected by this quality nonconformity.
In this respect, the NAMMDR has requested Marketing Authorisation Holders for these medicines to submit the following:
– an evidence of valid manufactured batches currently both held in their own warehouse and already distributed within the pharmaceutical network (warehouses and pharmacies), as well as of the batches manufactured and not yet released for sale;
– an inventory of distributors to whom the ranitidine containing batches have been distributed and the evidence of their notification on the barring from sale measure;
– an evidence of the quantities held in their own warehouse of the active substance ranitidine hydrochloride from manufacturers with suspended CEPs.
Under the circumstances, the NAMMDR advises healthcare professionals on the market availability of alternative treatments and recommends that patients see their doctor in this regard.

15.01.2020
To the attention of interested persons
Minister of Health Dr. Victor Costache, has appointed Ms. Roxana Stroe, MD, as President of the National Agency for Medicines and Medical Devices of Romania (NAMMDR) as of January 14, 2020.
Ms. Roxana Stroe, MD, is a Senior Physician in Clinical Pharmacology She has been working in the Agency since the end of 2010 and has been Coordinator of the Agency’s Pharmacovigilance and Risk Management Directorate. Since 2014, she has been a member of the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee, and an alternate member of the EMA’s Management Board since March 2019.
According to the appointing Minister of Health Order, Dr. Roxana Stroe’s position as President is temporary, pending the contest for the President position or revocation, according to legislation in force.
The duties of the newly appointed President are both achievement of objectives within the NAMMDD scope and development of the strategy for transparent and fair conduct of competitions for filling the Agency’s President and Vice President positions, in line with a competition methodology validated by reputable specialists in the field.

10.07.2018
To the attention of interested persons
The National Agency for Medicines and Medical Devices has requested precautionary recall from the Romanian market of all medicinal products containing valsartan manufactured by the Zhejiang Huahai Pharmaceuticals manufacturers in China, pursuant to recent identification of impurities introduced by the active substance manufacturing process.
download document …

13.03.2018
To the attention of interested persons
EMA press release: Prostate cancer medicine Xofigo must not be used with Zytiga and prednisone/prednisolone.
http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2018/03/WC500245412.pdf

09.03.2018
To the attention of interested persons
Press release: EMA recommends immediate suspension and recall of multiple sclerosis medicine Zinbryta.
NAMMD mention: Zinbryta (daclizumab) is not marketed in Romania on publication of this press release.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2018/03/news_detail_002920.jsp&mid=WC0b01ac058004d5c1

07.03.2018
To the attention of interested persons
Given the current immunoglobulin crisis on the Romanian market and publication in the press of erroneous information about the application submitted by supplier Torus Pharma, in view of release of a special needs authorisation for human immunoglobulin, the NAMMD hereby states the following:
The initial application, submitted on 28.12.2017, was not compliant with the provisions of Order of the Minister of Health no. 85/2013 on approval of the Norms for implementation of provisions of Article 699 (1) and (2) of Law No. 95/2006 on healthcare reform concerning medicinal products for special needs, referring to, among others, the lack of medical justification issued by special commissions/directorates of the Ministry of Health, thus prompting the NAMMD to require supplementations in January 2018.
In the beginning of February 2018, supplier Torus Pharma sent supplementations to the authorisation dossier, on behalf of two Ministry of Health advisory commissions, which have highlighted the fact that the product, manufactured in India, has a composition „slightly inferior as opposed to that of similar products previously available on the pharmaceutical market, due to a smaller IgG and a bigger IgA content”.
Moreover, the NAMMD states that this category of medicinal products – blood or plasma-derived medicinal products – involves particular risks in terms of viral safety. Since the respective product is authorised in a non-EU country, rigorous manufacturing and control according to European standards cannot be ensured, as regards: the system of donor selection, authorisation of collecting centres, testing of individual donations, the standard of sensitivity of employed methods, their validation, the traceability system of donations until finished product, also involving maintenance of donation data for a 30-year period, viral safety trials conducted during the manufacturing process, with assessment of the ability of viral elimination/inactivation, etc. All these issues, detailed in the context of EMA guidelines which should be observed by blood-derived product manufacturers, are corroborated with the existence of a non-EU GMP certificate.
Considering the aforementioned issues, the NAMMD considers that the non-EU origin of the product cannot guarantee the safety and quality criteria imposed for EU products, and the authorisation for special needs does not allow, in this case (see Order of the Minister of Health no. 85/2013), neither sufficient assessment in terms of safety and quality of the plasma used in the manufacturing process, nor that of the product’s manufacturing process. Moreover, the NAMMD states that, in this case, a punctual testing of the finished product could not cover all previously mentioned aspects and could not fully guarantee the product’s quality.
The NAMMD wishes to assure its patients and the public that it strictly adheres to its mission to promote and protect public health by ensuring marketing of medicinal products compliant with top quality, safety and efficacy standards.

16.02.2018
To the attention of interested persons
The National Agency for Medicines and Medical Devices (NAMMD) had the honour to host the first workday of the 4th edition of the Patients’ School Masterclass, organised by the Health Policies Magazine and by the the Coalition of Organisations of patients with chronic diseases (COPAC).
The following participants have replied to questions and manifested total openness toward efficient and constructive communication with patient associations:
Conf. Univ. Dr. Diana Paun – State Counsellor, Presidential Administration
Sorina Pintea – Minister of Health
Dr. Octavian Alexandrescu – Secretary of State – Ministry of Health
Dr. Alexandru Velicu – NAMMD President
Razvan Vulcanescu – NHIH President
Conf. Univ. Dr. Florin Buicu – President of the Health and Family Commission, Chamber of Deputies
Emanuel-Gabriel Botnariu – member of the Commission for Public Health, Senate
Romana Furtuna – Counsellor of the Minister of Health on the relationship with patient associations and NGOs.
The NAMMD President has enforced the idea expressed by Sorina Pintea, the Minister of Health, stating the fact that the Agency is ruled by a young team, which has already identified most of the issues for which it is entitled to find solutions.
Once again, Dr. Velicu highlighted the fact that the role of the NAMMD, as highlighted by Conf. Univ. Dr. Diana Paun as well, is well defined and assumed by all Agency specialists.
The NAMMD is currently facing a real issue, mentioned by Conf. Univ. Dr. Buicu, a well-known situation which should be discussed publicly (reduced staff, implementation of the Unitary Pay Law, as well as the wish to avoid medicinal product recall or discontinuation in supply of the pharmaceutical market).
As regards the cooperation with the NHIH, the President said he had met President Razvan Vulcanescu several times, which has led to setup of a working group aiming to identify possibilities for reduction of bureaucracy between the two institutions, which he had noticed back in the days when he was the NAMMD Vice-President.
To conclude, Dr. Velicu reaffirmed his openness toward proactive communication with patient associations with whom, as he has already discussed with Radu Ganescu, the COPAC President, is about to sign a collaboration protocol, in view of establishing a partnership for identification of the association’s specific issues and of practical solutions for their resolution, and in order to promote an ethical, correct and transparent environment for communication.

13.02.2018
To the attention of interested persons
EMA press release: PRAC recommends that the marketing authorisation of the painkiller flupirtine be withdrawn.
download document …

13.02.2018
To the attention of interested persons
The EMA Pharmacovigilance Risk Assessment Committee recommends new measures to avoid valproate exposure in pregnancy.
download document …

13.02.2018
To the attention of interested persons
PRAC recommends updating measures for pregnancy prevention during retinoid use.
download document …

13.02.2018
To the attention of interested persons
EMA press release: Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing.
download document …

13.02.2018
To the attention of interested persons
The NAMMD has the pleasure to notify all its stakeholders on receipt of the final assessment reports of the Agency’s audit in the context of the HMA/EMA Joint Audit Program. The audit was conducted during 17-21 October 2016, together with the audit scheduled by the competent authority of Canada, as a state with which the EU has signed a Mutual Recognition Agreement (MRA), in view of assessment of the legislation implemented in Romania and of the GMP inspection system observed by the NAMMD, as a national competent authority in the field of the medicinal product for human use. Two auditors on behalf of the FDA (the US competent authority) have participated in this audit, as observers, and have surveyed the specific objectives established for the pharmaceutical sector, within the Transatlantic Trade and Investment Partnership.
The final assessment reports received from Health Canada (the Canadian authority) confirms the conclusion of an equivalence between the GMP-related national legislation and the GMP-related Canadian legislation, as well as between the inspection systems in this field. This is a result of the NAMMD activity and, by reciprocal recognition of GMP inspections, represents not only the reaffirmation of the efforts of NAMMD specialists, but also an access of Romanian medicinal product manufacturers to the Canadian market.

09.02.2018
To the attention of interested persons
A working meeting has taken place today at the site of the National Agency for Medicines and Medical Devices (NAMMD), with the participation of Sorina Pintea, Octavian Alexandrescu, Secretary of State within the Ministry of Health, Dr. Alexandru Velicu, NAMMD President, representatives of wholesale distributors of immunoglobulins and CN Unifarm SA, representatives of the NAMMD.
The Meeting’s theme was the crisis generated by the discontinuity in supply of the pharmaceutical market with immunoglobulins, medicinal products addressing the primary immunodeficiency disease, considering that manufacturers have benefitted from exemption from the clawback tax for two years.
The Minister of Health, Mrs. Sorina Pintea, has demanded accurate information about these medicinal products, as regards the possibility of ensuring the supply of immunoglobulins, in the coming period and hereinafter, in 2018.
Considering the extension of this crisis situation, MH representatives have announced the scheduling in February of a meeting with immunoglobulin manufacturers, who represent the first link in the supply chain of patients with such products.
According to the discussions, a certain amount of three types of immunoglobulins (IG Vena, Intratect and Gammanorm) is about to be marketed during the 1st quarter of 2018, with the possibility of ongoing supplementation.

30.01.2018
To the attention of interested persons
Hydroxyethyl-starch solutions for infusion to be suspended – CMDh endorses PRAC recommendation.
download document …

18.01.2018
To the attention of interested persons
PRAC recommends suspending hydroxyethyl-starch solutions for infusion from the market.
download document …

18.01.2018
To the attention of interested persons
The National Agency for Medicines and Medical Devices (NAMMD) joined the Ministry of Health in expressing, via a letter addressed to the Medical Directorate of the National Defence Ministry, its satisfaction concerning the perspective of relaunching of the Cantacuzino Institute and of recommencing vaccine manufacturing in Romania, given the official subordination of the institute to the National Defence Ministry.
NAMMD specialists reiterate their full willingness and openness to communication and sharing of expertise for implementation of EU regulations in the field of the medicinal product for human use. Thus, supporting the relaunching of such a strategically important institute represents is, for the Agency, both an honour and a duty to support the Romanian institute in order to once again become a European centre for vaccine manufacturing.

16.01.2018
To the attention of interested persons
As a reply to the recent press article (https://www.hotnews.ro/stiri-esential-22223144-vlad-mixich-fost-vicepresedinte-agentiei-nationale-medicamentului-anm-sunt-42-paznici-operatori-dar-doar-4-oameni-decid-daca-medicament-merita-sau-nu-fie-compensat.htm), the NAMMD wishes to inform its collaborators, partners, patients, public and all interested persons that it has the priority, for the upcoming period, of making amendments related to the organisation, operation, wage levels of employees and other issues, so as to ensure optimisation of the Agency’s activity.
Both specialists involved in assessment and authorisation of medicinal products for human use, in pharmaceutical inspection, pharmacovigilance, medical technologies assessment, authorisation of clinical trials conducted in Romania, in all issues related to medical devices, or in proposition of profile regulations, as well as the supporting staff of the Agency, perform and develop their professional expertise under specific conditions, unique at national level. The appropriate amendment of the regulatory framework of the NAMMD organisation and operation is entitled to allow implementation of certain working conditions, comparable to those of other competent authorities in the field, without which the Agency’s mission within the EU network of specific national authorities cannot be optimally fulfilled.
Given its good relationship with the Ministry of Health, the NAMMD expresses its belief according to which its ongoing approaches shall have a happy end, thus leading to a good performance of the NAMMD activity, whose main purpose is the safeguard of public health.

12.01.2018
To the attention of interested persons
In the context of recent press articles, the National Agency for Medicines and Medical Devices (NAMMD) reminds the importance of appropriate use of ibuprofen-containing medicinal products.
download document …

20.12.2017
To the attention of interested persons
Modified-release paracetamol-containing products to be suspended from EU market.
download document …

20.12.2017
To the attention of interested persons
EMA press release on updated recommendations for contraception in men and women taking mycophenolate medicines.
download document …

11.12.2017
To the attention of interested persons
PRAC confirms that modified-release paracetamol should be suspended from market.
download document …

11.12.2017
To the attention of interested persons
EMA starts review of Esmya for uterine fibroids.
download document …

11.12.2017
To the attention of interested persons
Warning about use of prostate cancer medicine Xofigo in combination with Zytiga and prednisone or prednisolone.
download document …

20.11.2017
To the attention of interested persons
Contribute to better medicinal product safety by reporting suspected adverse drug reactions!
The National Agency for Medicines and Medical Devices (NAMMD) is launching the second social media campaign for the general public.
download document …

15.11.2017
To the attention of interested persons
EMA concludes review of Zinbryta and confirms further restrictions to reduce risk of liver damage.
download document …

03.11.2017
To the attention of interested persons
Review of flupirtine-containing medicines started.
download document …

01.11.2017
To the attention of interested persons
EMA starts new review of hydroxyethyl-starch containing medicines.
download document …

01.11.2017
To the attention of interested persons
PRAC recommends further restrictions for multiple sclerosis medicine Zinbryta due to risk of serious liver damage.
download document …

30.10.2017
To the attention of interested persons
NAMMD position in response to recent press allegations
The National Agency for Medicines and Medical Devices (NAMMD) is surprised to find from the media that it allegedly had refused donations in the aftermath of the Collective Club related tragedy: “To address the NMA and the ministry and to be sent home and be advised not to make a stir with one’s donations…. And it was not just our company to be turned down…”
For proper information of the general public, of patients and media representatives who give due regard to their own calling by upholding the truth, the NAMMD would like to hereby make the following clarifications on:
– the legal basis of donations: Order of the Minister of Health no. 1032/2011 for approval of Rules on donations of medicinal products, sanitation supplies, medical devices, vaccines, sera and related supplies
– issue on 6 November 2015 of Order of the Minister of Health no. 1409/2015 for waiver from provisions of Article 10 of the Rules on donations of medicinal products, sanitation supplies, medical devices, vaccines, sera and related supplies, approved through Order of the Minister of Health no. 1032/2011, regarding healthcare facilities with beds delivering medical services to in-patient casualties of the Collective Club and the Vel Pitar Brasov factory incidents.
Accordingly, donations have been accepted of medication containing psychotropic and narcotic drugs, necessary for fire in-patients.
– emergency grant by the NAMMD from 4 November to 12 December 2015 of 10 approvals for donation, all concerning medications intended for major burn patients, hospitalised in various Bucharest hospitals;
– emergency grant by the NAMMD, on request by the Ministry of Health Advisory Commission for Plastic Surgery, Aesthetic and Reconstructive Microsurgery of Authorisations for special needs medicines for two products.
The NAMMD hereby points out its deep regret at the defamation of its work, ultimately so often unjustifiably engendering patients and the general public’s confusion and mistrust!! In this regard, the NAMMD would like to require the former Minister of Health, Mr. Vlad Voiculescu, to provide actual data on the company/companies whose messages he relays in his Facebook page, thus enabling the Agency to perform all verifications necessary.

10.10.2017
To the attention of interested persons
Countdown to launch of new EudraVigilance System: final preparations for change-over to new system underway for go live date on 22 November 2017
download document …

06.10.2017
To the attention of interested persons
EMA press release: PRAC recommends modified-release paracetamol be removed from market (update: 29 September 2017)
download document …

25.09.2017
To the attention of interested persons
EMA concludes review of human factor VIII medicines authorised in EU
download document …

11.09.2017
To the attention of interested persons
EMA press release: PRAC recommends modified-release paracetamol be removed from market
download document …

07.09.2017
To the attention of interested persons
PRAC confirms its previous conclusion on risk of inhibitor development with factor VIII medicines
download document …

16.08.2017
To the attention of interested persons
EMA seeks views of public during its safety review of valproate Registration opens for first public hearing
download document …

04.08.2017
To the attention of interested persons
CMDh confirms that methylprednisolone injections containing lactose must not be given to patients allergic to cow’s milk proteins
download document …

31.07.2017
To the attention of interested persons
EMA’s final opinion confirms restrictions on use of linear gadolinium agents in body scans – Recommendations conclude EMA’s scientific review of gadolinium deposition in brain and other tissues
download document …

11.07.2017
To the attention of interested persons
EMA restricts use of multiple sclerosis medicine Zinbryta
download document …

11.07.2017
To the attention of interested persons
PRAC recommends that injectable methylprednisolone products containing lactose must not be given to patients allergic to cow’s milk proteins
download document …

10.07.2017
To the attention of interested persons
PRAC confirms restrictions on the use of linear gadolinium agents
download document …

29.06.2017
To the attention of interested persons
EMA recommends that Symbioflor 2 can continue to be used for irritable bowel syndrome
download document …

14.06.2017
To the attention of interested persons
PRAC concludes there is no evidence of a change in known risk of neutropenic enterocolitis with docetaxel
download document …

13.06.2017
To the attention of interested persons
EMA reviews multiple sclerosis medicine Zinbryta
download document …

12.06.2017
To the attention of interested persons
PRAC concludes there is no clear and consistent evidence of a difference in inhibitor development between classes of factor VIII medicines
download document …

25.05.2017
To the attention of interested persons
Announcement of the EMA Management Board – Confirmation of full functionality of the EudraVigilance database
download document …

23.05.2017
To the attention of interested persons
EMA recommends changes to prescribing information for vancomycin antibiotics
download document …

12.05.2017
To the attention of interested persons
The NAMMD hereby informs on publication of the EMA annual report for 2016
download document …

12.05.2017
To the attention of interested persons
The National Agency for Medicines and Medical Devices would like to invite all stakeholders to take part in the survey launched by the European Medicines Agency.
download document …

09.05.2017
To the attention of interested persons
EMA press release: PRAC concludes there is no clear and consistent evidence of a difference in inhibitor development between classes of factor VIII medicines
download document …

12.04.2017
To the attention of interested persons
EMA concludes safety review of Uptravi
download document …

12.04.2017
To the attention of interested persons
PRAC concludes assessment of gadolinium agents used in body scans and recommends regulatory actions, including suspension for some marketing authorisations – Update of 7 Aprilie 2017
download document …

27.03.2017
To the attention of interested persons
EMA recommends suspension of medicines due to unreliable studies from Micro Therapeutic Research Labs
download document …

14.03.2017
To the attention of interested persons
EMA press release: PRAC concludes assessment of gadolinium agents used in body scans and recommends regulatory actions, including suspension for some marketing authorisations
download document …

14.03.2017
To the attention of interested persons
EMA press release on new review of valproate use in pregnancy and women of childbearing age
download document …

14.03.2017
To the attention of interested persons
EMA reviewing cancer medicine docetaxel
download document …

06.03.2017
To the attention of interested persons
The National Agency for Medicines and Medical Devices (NAMMD), member of the European network of National Competent Authorities (NCAs) coordinated by the European Medicines Agency (EMA) expresses its satisfaction due to the agreement signed between regulatory authorities in the EU and the US, concerning mutual recognition of inspections conducted at medicinal product manufacturing sites.
The agreement will enable both the EU authorities and the FDA to make better use of their inspection resources to help them to focus on other parts of the world where active pharmaceutical ingredients and medicinal products for the EU or US markets are manufactured. This will ensure that patients can rely on the quality, safety and efficacy of all medicinal products, no matter where they have been produced.
The agreement is underpinned by robust evidence that the EU and the US have comparable regulatory and procedural frameworks for inspections of manufacturers of human medicines. In this context, it is worth mentioning that the NAMMD complies with the procedural framework imposed by EU legislation for pharmaceutical inspections.
Teams from the European Commission, NCA, EMA and FDA have been audited and assessing the respective supervisory systems since May 2014, and have worked closely together to reach this agreement.
The Agreement is an Annex to the EU-US Mutual Recognition Agreement which was signed in 1998, but is not yet implemented. Many provisions of the agreement have already entered into force and others will enter into force on 1 November 2017. The text of the Agreement is now published on the website of the European Commission’s Directorate General for Trade.

27.02.2017
To the attention of interested persons
Ema press release on SGLT2 inhibitors: information on potential risk of toe amputation to be included in prescribing information
download document …

14.02.2017
To the attention of interested persons
EMA to review persistence of side effects known to occur with quinolone and fluoroquinolone antibiotics
download document …

14.02.2017
To the attention of interested persons
EMA reviewing safety of Uptravi for pulmonary arterial hypertension
download document …

14.02.2017
To the attention of interested persons
EMA press release: PRAC concludes that diabetes medicine canagliflozin may contribute to risk of toe amputation
download document …

01.02.2017
To the attention of interested persons
EMA press release: Dienogest/ethinylestradiol can be used for acne after certain other treatments have failed
download document …

18.01.2017
To the attention of interested persons
Considering the obligation, in accordance with legislation in force, of declaring sponsoring by manufacturers, MAHs or their representatives in Romania, wholesale and retail distributors of medicinal products in Romania, as well as by respective recipients, before 31 March 2017, the NAMMD recommends the use of electronic declaration forms and the Guidelines on completion of declaration forms, online for recipients and by e-mail for sponsors, available on the NAMMD website, at http://www.anm.ro/en/medicamente-de-uz-uman/publicitate/sponsorizari-medicamente-de-uz-uman/.

21.12.2016
To the attention of interested persons
EMA press release on direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B
download document …

21.12.2016
To the attention of interested persons
EMA press release on start of a review concerning the conduct of studies at Micro Therapeutic Research Labs, India
download document …

08.12.2016
To the attention of interested persons
The National Agency for Medicines and Medical Devices (NAMMD) would like to announce the launch of the online Form for reporting suspected adverse reactions to medicinal products, the fastest and most up-to-date manner of reporting. The online form has been elaborated with support from colleagues from the fellow medicinal product competent authority of the United Kingdom , in the context of the Joint action project „Strengthening Collaboration for Operating Pharmacovigilance in Europe –SCOPE Joint Action”, financed by the European Union Health Programme.
Reporting of suspected adverse reaction to medicinal products is important; it is the only way you can contribute to better medicinal product safety.

08.12.2016
To the attention of interested persons
EMA press release: PRAC warns of risk of hepatitis B re-activation with direct-acting antivirals for hepatitis C
download document …

20.10.2016
To the attention of interested persons
Press release: EMA recommends measures to ensure safe use of Keppra oral solution
download document …

19.10.2016
To the attention of interested persons
EMA press release: Use of metformin to treat diabetes now expanded to patients with moderately reduced kidney function
download document …

21.09.2016
To the attention of interested persons
EMA press release: Pharmaceutics International Inc., US: supply of noncritical medicines to EU to be stopped due to manufacturing failings
download document …

09.08.2016
To the attention of interested persons
EMA press release: Adaptive pathways: key learnings and next steps EMA publishes report on pilot project and will organise workshop in December to further explore concept
download document …

09.08.2016
To the attention of interested persons
EMA press release: EU collaboration strengthens safety monitoring of medicines
download document …

26.07.2016
To the attention of interested persons
EMA press release: CHMP confirms recommendations for use of Zydelig
download document …

26.07.2016
To the attention of interested persons
EMA recommends suspension of medicines over flawed studies at Semler Research Centre
download document …

17.07.2016
To the attention of interested persons
EMA press release: Proposals to revise guidance on first-in-human clinical trials
download document …

11.07.2016
To the attention of interested persons
EMA press release: Review of factor VIII medicines and risk of developing inhibitors in patients starting treatment for haemophilia A
download document …

11.07.2016
To the attention of interested persons
EMA press release: EMA starts review of retinoid medicines
download document …

11.07.2016
To the attention of interested persons
EMA press release: EMA to review modified-release paracetamol
download document …

11.07.2016
To the attention of interested persons
EMA press release: PRAC concludes review of Zydelig and issues updated recommendations for use
download document …

29.06.2016
To the attention of interested persons
EMA press release on start of review of medicines manufactured at Pharmaceutics International Inc., USA
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29.06.2016
To the attention of interested persons
EMA press release: Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU
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29.06.2016
To the attention of interested persons
EMA warns that Noxafil tablets and oral suspension have different doses and are not interchangeable
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29.06.2016
To the attention of interested persons
EMA press release: Adempas not for use in patients with pulmonary hypertension caused by idiopathic interstitial pneumonia
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15.06.2016
To the attention of interested persons
EMA press release: Single, central platform now mandatory for all periodic safety update reports
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30.05.2016
To the attention of interested persons
EMA press release: Improving safety of first-in-human clinical trials
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18.05.2016
To the attention of interested persons
EMA press release on inhibitor development in previously untreated patients with severe haemophilia A treated with recombinant factor VIII products
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05.05.2016
To the attention of interested persons
EMA press release on start of a review on the conduct of studies at Semler Research Centre Private Ltd, Bangalore, India
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05.05.2016
To the attention of interested persons
EMA press release on completion of review of inhaled corticosteroids for chronic obstructive pulmonary disease
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20.04.2016
To the attention of interested persons
EMA press release: Listening to the public’s views on the safety of medicines
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20.04.2016
To the attention of interested persons
Press release: EMA reviews direct-acting antivirals for hepatitis C
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19.04.2016
To the attention of interested persons
Press release: EMA reviews diabetes medicine canagliflozin
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04.04.2016
To the attention of interested persons
EMA press release on start of a review concerning the conduct of studies at the Alkem Laboratories Ltd site, Taloja, India
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04.04.2016
To the attention of interested persons
EMA press release: Review of Symbioflor 2 started
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04.04.2016
To the attention of interested persons
EMA press release: CMDh endorses revocation of authorisations for fusafungine sprays used to treat airway infections
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01.04.2016
To the attention of interested persons
EMA press release: Review of vancomycin-containing medicines started
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22.03.2016
To the attention of interested persons
EMA press release on review of gadolinium contrast agents used in MRI scans
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22.03.2016
To the attention of interested persons
EMA press release: PRAC reviews known risk of pneumonia with inhaled corticosteroids for chronic obstructive pulmonary disease
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21.03.2016
To the attention of interested persons
EMA press release on review of direct-acting antivirals for hepatitis C
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21.03.2016
To the attention of interested persons
EMA press release on recommendation of new safety measures for Zydelig
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02.03.2016
To the attention of interested persons
EMA confirms recommendations to minimise risk of brain infection PML with Tysabri
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02.03.2016
To the attention of interested persons
EMA confirms recommendations to minimise ketoacidosis risk with SGLT2 inhibitors for diabetes
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02.03.2016
To the attention of interested persons
EMA press release on start of review of medicines containing dienogest 2 mg and ethinylestradiol 0.03 mg for acne
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17.02.2016
To the attention of interested persons
EMA press release on SGLT2 inhibitors: PRAC makes recommendations to minimise risk of diabetic ketoacidosis
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17.02.2016
To the attention of interested persons
EMA press release on updated recommendations to minimise the risk of the rare brain infection PML with Tysabri
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16.02.2016
To the attention of interested persons
EMA press release: PRAC recommends that fusafungine nose and mouth sprays are no longer marketed
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09.02.2016
To the attention of interested persons
Press release: EMA concludes defective device in ROCKET study does not impact Xarelto’s safety
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09.02.2016
To the attention of interested persons
Press release: EMA sets up task force on Zika virus
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02.02.2016
To the attention of interested persons
EMA press release: Review of metformin-containing medicines started
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29.12.2015
To the attention of interested persons
EMA press release on new recommendations to minimise risks of the rare brain infection PML (Progressive multifocal leukoencephalopathy) and a type of skin cancer with Gilenya (fingolimod)
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24.11.2015
To the attention of interested persons
EMA press release on HPV vaccines: EMA confirms evidence does not support that they cause CRPS or POTS
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06.11.2015
To the attention of interested persons
EMA press release: review concludes evidence does not support that HPV vaccines cause CRPS or POTS
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28.10.2015
To the attention of interested persons
EMA press release on recommendation of additional measures to prevent use of mycophenolate in pregnancy
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28.10.2015
To the attention of interested persons
EMA press release: Inductos to be suspended in the EU
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28.10.2015
To the attention of interested persons
EMA press release on Updated recommendations to minimise the risk of the rare brain infection PML with Tecfidera
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28.10.2015
To the attention of interested persons
EMA press release on updated advice on body fat changes and lactic acidosis with HIV medicines
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14.09.2015
To the attention of interested persons
EMA press release on start of review of nasal and mouth sprays containing fusafungine
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29.07.2015
To the attention of interested persons
Press release: EMA to review Inductos
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14.07.2015
To the attention of interested persons
EMA press release: EMA to further clarify safety profile of human papillomavirus (HPV) vaccines
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07.07.2015
To the attention of interested persons
EMA press release on improving safety of medicines across Europe
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30.06.2015
To the attention of interested persons
EMA press release on better training tools recommended to support patients using adrenaline auto-injectors
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16.06.2015
To the attention of interested persons
EMA press release on review of diabetes medicines called SGLT2 inhibitors started
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27.05.2015
To the attention of interested persons
EMA press release on updated advice on use of high-dose ibuprofen
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13.05.2015
To the attention of interested persons
EMA press release: review of Tysabri started
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13.05.2015
To the attention of interested persons
EMA press release on start of review of inhaled corticosteroids for chronic obstructive pulmonary disease
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28.04.2015
To the attention of interested persons
EMA press release: Codeine not to be used in children below 12 years for cough and cold
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28.04.2015
To the attention of interested persons
EMA recommends avoidance of certain hepatitis C medicines and amiodarone together
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16.04.2015
To the attention of interested persons
EMA press release on PRAC recommends updating advice on use of high-dose ibuprofen
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31.03.2015
To the attention of interested persons
EMA press release on further measures to minimise risk of osteonecrosis of the jaw with bisphosphonate medicine
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31.03.2015
To the attention of interested persons
EMA press release on new restrictions to minimise the risks of effects on heart rhythm with hydroxyzine-containing medicines
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17.03.2015
To the attention of interested persons
EMA press release: PRAC recommends restrictions on the use of codeine for cough and cold in children
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17.03.2015
To the attention of interested persons
EMA press release: PRAC recommends further measures to minimise risk of osteonecrosis of the jaw with bisphosphonate medicine
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04.03.2015
To the attention of interested persons
The National Agency for Medicines and Medical Devices (NAMMD) hereby informs on availability of a form for reporting of adverse reactions to medicinal products, including vaccines, by patients, patient relatives or caregivers. The form for reporting adverse reactions available to patients, by means of which patients, their relatives or caregivers can notify adverse reactions following administration of medicinal products, vaccines included. The suspected adverse reaction reporting form is posted on the NAMMD website, together with a number of related clarifications and pieces of information…
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02.03.2015
To the attention of healthcare professionals
EMA press release: Ambroxol and bromhexine expectorants: safety information to be updated
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24.02.2015
To the attention of healthcare professionals
The NAMMD hereby informs on results of tests conducted in NAMMD laboratories on samples of Imovax dT (marketing authorisation holder: Sanofi Pasteur SA, France), sampled from batches for which potential adverse reactions have been reported after vaccination in children aged 14, in accordance with the approved vaccination schedule in Romania.
No quality non-compliances have been detected and laboratory test results are compliant with manufacturer’s product specifications for the finished product and corresponding PhEur monograph from the European Pharmacopoeia.

18.02.2015
To the attention of healthcare professionals
EMA press release: PRAC recommends new measures to minimise known heart risks of hydroxyzine-containing medicines
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27.01.2015
To the attention of healthcare professionals
EMA press release on GVK Biosciences: European Medicines Agency recommends suspending medicines over flawed studies
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27.01.2015
To the attention of healthcare professionals
Questions and answers on public consultation on implementation of transparency requirements of the European Clinical Trial Regulation
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27.01.2015
To the attention of healthcare professionals
EMA press release on CHMP summary of positive opinion for Vantobra (tobramycin)
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23.01.2015
To the attention of healthcare professionals
EMA press release on public consultation on application of transparency rules of EU Clinical Trial Regulation
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16.12.2014
To the attention of healthcare professionals
EMA press release: Experimental Ebola treatments still at early stage of development
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09.12.2014
To the attention of healthcare professionals
EMA press release on GVK Biosciences review: some Member States suspend marketing authorisations for concerned medicines
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02.12.2014
To the attention of healthcare professionals
EMA press release: No evidence that Fluad vaccine caused deaths in Italy
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02.12.2014
To the attention of healthcare professionals
EMA press release on Investigation into reports of serious adverse events following use of Fluad
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26.11.2014
To the attention of healthcare professionals
EMA press release: No consistent evidence of an increased risk of heart problems with testosterone medicines
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25.11.2014
To the attention of healthcare professionals
EMA press release: CMDh agrees to strengthen warnings on the use of valproate medicines in women and girls
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12.11.2014
To the attention of healthcare professionals
EMA press release: PRAC recommends measures to reduce risk of heart problems with Corlentor/Procoralan (ivabradine)
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04.11.2014
To the attention of healthcare professionals
EMA press release: European Medicines Agency recommends further measures to minimise risk of blood vessel blockage with Iclusig
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29.10.2014
To the attention of healthcare professionals
EMA press release: European Medicines Agency completes review of polymyxin-based medicines
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16.10.2014
To the attention of healthcare professionals
EMA press release: PRAC recommends further measures to minimise risk of blood vessel blockage with Iclusig
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16.10.2014
To the attention of healthcare professionals
EMA press release: PRAC recommends strengthening the restrictions on the use of valproate in women and girls
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14.10.2014
To the attention of healthcare professionals
EMA press release: PRAC review does not confirm increase in heart problems with testosterone medicines
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08.10.2014
To the attention of healthcare professionals
EMA press release: Information on suspected side effects of nationally authorised medicines now available through a single website
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03.10.2014
To the attention of healthcare professionals
EMA confirms positive benefit-risk for antidepressant Valdoxan/Thymanax (agomelatine)
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03.10.2014
To the attention of healthcare professionals
Ebola outbreak: EMA to review experimental medicines to support treatment decisions
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03.10.2014
To the attention of healthcare professionals
EMA press release: Start of a review concerning the conduct of studies at GVK Biosciences site in Hyderabad, India
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03.10.2014
To the attention of healthcare professionals
EMA press release on Closure of EU manufacturing site for MACI
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03.10.2014
To the attention of healthcare professionals
EMA press release: Ketoconazole HRA recommended for approval in Cushing’s syndrome
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27.08.2014
To the attention of healthcare professionals
CMDh endorses restricted use of bromocriptine for stopping breast milk production
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01.08.2014
To the attention of healthcare professionals
CMDh endorses suspension of methadone oral solutions containing high molecular weight povidone
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01.08.2014
To the attention of healthcare professionals
Levonorgestrel and ulipristal remain suitable emergency contraceptives for all women, regardless of bodyweight
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15.07.2014
To the attention of healthcare professionals
EMA press release: PRAC recommends suspension and reformulation of oral methadone solutions containing high molecular weight povidone
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15.07.2014
To the attention of healthcare professionals
EMA press release: PRAC recommends restricted use of bromocriptine-containing medicinal products
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17.06.2014
To the attention of healthcare professionals
EMA starts review of ibuprofen medicines;
Review to evaluate cardiovascular risk with high doses taken over long periods
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28.05.2014
To the attention of healthcare professionals
EMA press release on combined use of medicines affecting the renin-angiotensin system (RAS) to be restricted – CHMP endorses PRAC recommendation
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14.05.2014
To the attention of healthcare professionals
EMA press release: Review of Corlentor/Procoralan started
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13.05.2014
To the attention of healthcare professionals
EMA press release: Review of hydroxyzine-containing medicines started
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05.05.2014
To the attention of healthcare professionals
EMA press release: Review of adrenaline auto-injectors started
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05.05.2014
To the attention of healthcare professionals
European Medicines Agency recommendations on the use of Linoladiol N and Linoladiol HN estradiol-containing creams
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05.05.2014
To the attention of healthcare professionals
EMA press release: CMDh confirms recommendations on restricting use of domperidone-containing medicines
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30.04.2014
To the attention of healthcare professionals
CMDh endorses new advice to minimise risk of next-morning impaired driving ability and mental alertness with zolpidem
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29.04.2014
To the attention of healthcare professionals
European Medicines Agency recommends revoking authorisations of Caustinerf arsenical and Yranicid arsenical used in dental procedures
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23.04.2014
To the attention of healthcare professionals
European Medicines Agency update on stolen vials of Herceptin
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16.04.2014
To the attention of healthcare professionals
European Medicines Agency alerts EU healthcare professionals after vials of falsified Herceptin identified
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15.04.2014
To the attention of healthcare professionals
EMA press release: PRAC recommends against combined use of medicines affecting the renin-angiotensin (RAS) system
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15.04.2014
To the attention of healthcare professionals
EMA press release: Review of oral methadone medicines containing povidone started
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15.04.2014
To the attention of healthcare professionals
EMA press release: Start of review of codeine-containing medicines when used for cough and cold in children
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15.04.2014
To the attention of healthcare professionals
EMA press release: Start of review of ambroxol and bromhexine
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15.04.2014
To the attention of healthcare professionals
EMA press release: Review of testosterone-containing medicines started
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26.03.2014
To the attention of healthcare professionals
CMDh endorses recommendations to restrict the use of diacerein-containing medicines
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17.03.2014
To the attention of healthcare professionals
EMA press release: PRAC recommends product information of zolpidem be updated with new advice to minimise the risk of next-morning impaired driving ability and mental alertness
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17.03.2014
To the attention of healthcare professionals
EMA press release: PRAC recommends restricting use of domperidone
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17.03.2014
To the attention of healthcare professionals
EMA press release: PRAC re-examines diacerein and recommends that it remain available with restrictions
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26.02.2014
To the attention of stakeholder
NAMMD Press Release on the situation ensued from non-compliance of influenza seasonal vaccine batches manufactured by the Cantacuzino Institute for 2013-2014

According to Article 826 of Law 95/2006 on healthcare reform, as amended, Title XVII – The medicinal product, transposing Directive 2001/83/CE of the European Parliament and the Council on the Community code relating to medicinal products for human use, as amended, the National Agency for Medicines and Medical Devices (NAMMD) is in charge of official batch release for immunologic or blood/plasma-derived medicinal products manufactured in Romania, third countries or EU Member States for which official batch release has not been performed by a control authority and for which marketing is only performed in Romania.
Samples from all the eight batches of influenza vaccine manufactured by the Cantacuzino Institute have been tested in the NAMMD laboratories according to the corresponding monograph of the European Pharmacopoeia, in force. Following laboratory testing of samples submitted, out-of-specification results have been obtained for one of the tested parameters, i.e. Bacterial endotoxins for all samples tested. Mention should be made that, for all the other parameters tested, results have been within admitted limits. In consequence of the non-compliance found for all vaccine batches newly manufactured by the Cantacuzino Institute, re-testing of sample has been performed at the NAMMD site, followed by re-testing in the presence of the manufacturer.
Results found at re-testing at both the NAMMD site in the presence of Cantacuzino Institute representatives and at manufacturer’s site, with NAMMD representatives, have confirmed the non-compliance found regarding content of Bacterial Endotoxins over the accepted limits (max 100 IU/ vaccine dose). The method for testing of Bacterial Endotoxins content as indicated by the manufacturer and according to provisions of the European Pharmacopoeia monograph has been the gel-clot method (a qualitative method).
On 23.12.2013, the NAMMD sent a notification letter to the Ministry of Health, to the attention of Minister Eugen Nicolaescu, on the non-compliance found, determining as a consequence the impossibility to perform official batch release of the Cantacuzino Institute manufactured vaccine batch and the need to issue a Non-compliance notice.
On 24.12.2013, the Non-compliance notices were collected from the NAMMD headquarters by a representative of the Cantacuzino Institute.
Having in mind the potential impact of this non-compliant result on the public concerning the national seasonal influenza immunisation plan 2013-2014, in the context of Cantacuzino Institute reinstatement of manufacture and its strategic importance for Romania as well as the determination that NAMMD laboratory testing results be without doubt, the NAMMD management has decided to send a vaccine sample to be tested in the certified OMCL (Official Medicines Control Laboratories) laboratory of the French competent authority. The sample submitted for testing was part of a sample taken according to procedure in force for testing in the NAMMD laboratory. The method used by the French laboratory for testing of the Bacterial Endotoxins content is a quantitative method also included in the European Pharmacopoeia for this parameter, i.e. the kinetic-chromogenic method.
On 31.01.2014, the NAMMD received the first confirmation of the non-compliant result from the French laboratory concerning Bacterial Endotoxins content; on 05.02.2014, the result notified on 31.01.2014 was re-confirmed.
The result received from the French competent authority practically confirmed the accuracy of the result issued by the NAMMD in its Non-compliance notices, once again highlighting, in quantitative terms this time, the Bacterial Endotoxins content, ascertained to exceed the limits specified in the European Pharmacopoeia, i.e. maximum 100 IU/ vaccine dose.
To conclude, the NAMMD has not performed official batch release of the new influenza vaccine batches manufactured by the Cantacuzino Institute, which once again proves that the Romanian competent authority actually fulfils its primary mission as guarantor of the quality of medicinal products for human use authorised for marketing in Romania, protecting and promoting public health.

25.02.2014
To the attention of healthcare professionals
European Medicines Agency recommends that Protelos/Osseor remain available but with further restrictions
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25.02.2014
To the attention of healthcare professionals
European Medicines Agency recommends restricting the use of methysergide-containing medicines
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18.02.2014
To the attention of healthcare professionals
EMA press release: Review of emergency contraceptives started
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17.01.2014
To the attention of stakeholder
In the past two days, Romanian television and written press representatives have displayed particular interest in the potential adverse reactions of Paracetamol, following an article from the US press. The article does not contribute with additional aspects to known information available in the package leaflet of all paracetamol-containing medicinal products in the European Union.
The respective information refers to recommended usual doses, i.e. 1-2 tablets taken every 4 hours, as needed, the maximum recommended dose (4g for adults, 60 mg/kg/day divided into equal doses for children 6 to 12 years old), potential adverse reactions (skin rash, itching, low platelet count, agranulocytosis accompanied by unexpected pharyngitis and fever, liver impairment, renal colic. Elevated paracetamol doses and prolonged treatment may determine impaired renal function leading to chronic kidney failure.
Product information also specifies the potential renal impairment risk when taking paracetamol with alcohol, or the risk of combining paracetamol with other medicinal products.
This information is detailed, harmonised in the entire European Union and, as in all package leaflets, stresses that adverse reactions are an issue for all medicinal products, although they may not occur in all individuals.
The NAMMD hereby points out the importance of compliance with recommended doses to ensure the health of all patients by avoiding, as much as possible, the occurrence of adverse reactions.

14.01.2014
To the attention of healthcare professionals
On 10 January 2013, the European Medicines Agency (EMA) issued a press release on the recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC) to suspend the use of strontium ranelate-containing medicines Protelos and Osseor.
The PRAC conducted a review of the benefits of these medicinal products, as well as a review of their known risks (myocardial infarction, venous thromboembolism, severe cutaneous reactions) and concluded that the benefit-risk balance for these products is no longer positive, recommending that the use of Protelos/Osseor be suspended until new data attesting a positive benefit-risk balance for a limited group of patients is available.
While in April 2013 the PRAC recommended the restriction in the use of strontium ranelate, following a routine assessment of its benefit-risk balance, in January 2014, following an in-depth review of its safety profile, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee recommended the suspension of its use in the treatment of osteoporosis.
At this stage, until new data becomes available confirming usefulness of this product for a certain population segment is available and until issuance of a European Commission Decision based on the final opinion of EMA’s Committee for Medicinal Products for Human Use (CHMP) to be formulated after its meeting of 20-23 January 2014, physicians are advised to take particular care when prescribing these medicinal products.

14.01.2014
To the attention of healthcare professionals
PRAC recommends suspending use of Protelos/Osseor (strontium ranelate)
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13.01.2014
To the attention of healthcare professionals
CHMP confirms PRAC recommendations on Kogenate Bayer/Helixate NexGen
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08.01.2014
To the attention of healthcare professionals
The European Medicines Agency recommends that estradiol-containing creams Linoladiol N and Linoladiol HN remain available
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08.01.2014
To the attention of healthcare professionals
Acipimox only to be used as additional or alternative treatment to reduce high triglyceride levels
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11.12.2013
To the attention of healthcare professionals
EMA press release: Further review of Iclusig started
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10.12.2013
To the attention of healthcare professionals
PRAC considers benefits of Kogenate Bayer/Helixate NexGen outweigh risks in previously untreated patients
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05.12.2013
To the attention of healthcare professionals
European Medicines Agency recommends changes in use of leukaemia medicine Iclusig (ponatinib) in order to minimise risk of blood clots
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02.12.2013
To the attention of healthcare professionals
European Medicines Agency recommends restricting use of thiocolchicoside by mouth or injection
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26.11.2013
To the attention of healthcare professionals
Benefits of combined hormonal contraceptives (CHCs) continue to outweigh risks – CHMP endorses PRAC recommendation
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20.11.2013
To the attention of healthcare professionals
European Medicines Agency finalises review of medicines concerned by Roche pharmacovigilance inspection
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18.11.2013
Press release
PRAC updates on the risks of serious vascular occlusive events associated with cancer medicine Iclusig
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14.11.2013
To the attention of healthcare professionals
PRAC recommends using acipimox only as additional or alternative treatment to lower high triglyceride levels
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14.11.2013
To the attention of healthcare professionals

PRAC recommends suspension of diacerein-containing medicines
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31.10.2013
To the attention of healthcare professionals
Restrictions on use of medicines containing ergot derivatives
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31.10.2013
To the attention of healthcare professionals
European Medicines Agency gives recommendations on the use of intravenous nicardipine
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29.10.2013
To the attention of healthcare professionals
Restrictions on use of short-acting beta-agonists in obstetric indications – CMDh endorses PRAC recommendations
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29.10.2013
To the attention of healthcare professionals
Batches of the insulin medicine NovoMix 30 FlexPen and Penfill to be recalled
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29.10.2013
To the attention of healthcare professionals
Hydroxyethyl-starch solutions (HES) should no longer be used in patients with sepsis or burn injuries or in critically ill patients – CMDh endorses PRAC recommendations
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25.10.2013
To the attention of healthcare professionals
Start of review of valproate and related substances
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16.10.2013
To the attention of healthcare professionals
PRAC confirms that hydroxyethyl – starch solutions (HES) should no longer be used in patients with sepsis or burn injuries or in critically ill patients HES will be available in restricted patient populations.
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16.10.2013
To the attention of healthcare professionals
PRAC confirms that benefits of all combined hormonal contraceptives (CHCs) continue to outweigh risks Committee recommends that women and prescribers be better informed of the known risk of thromboembolism and alert for signs and symptoms.
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31.07.2013
NAMMD press release
Press Release of the National Agency for Medicines and Medical Devices on recall of batches T737E and U299B of SUTENT 50 mg, capsules
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10.06.2013
To the attention of healthcare professionals
NAMMD press release on market withdrawal, at wholesale distributor level, of CILEST 0.250mg/0.035mg, tablets
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01.02.2013
To the attention of healthcare professionals
The National Agency for Medicines and Medical Devices is reviewing the safety profile of “Diane 35”
The National Agency for Medicines and Medical Devices advises physicians to explain patients the side effects of the medicinal product
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07.05.2012
To the attention of interested parties
Project launch: “NATIONAL E-LEARNING PLATFORM ON PHARMACEUTICAL REGULATION“ – co-financed from the Regional European Development Fund
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10.01.2012
To the attention of interested parties
In 2011, the National Agency for Medicines and Medical Devices (NAMMD) approved variation to marketing authorisation (MA) terms concerning the trivalent purified inactivated influenza vaccine (Marketing authorisation holder – INCDMI Cantacuzino) as regards its composition in accordance with composition approved by the World Health Organisation for the 2011/2012 season.
Following NAMMD approval, the Cantacuzino Institute has performed monitoring and monthly reporting to the NAMMD of outcomes of tests for each viral strain strength of the three viral strengths included in the vaccine.
To this date, monthly outcomes recorded have been within the approved quality parameters. The NAMMD has been informed from the latest tests performed on decrease in strength below the approved limit of one of the three viral strains in the vaccine composition.
The non-compliance submitted to the Agency concerned 7 out of the 18 vaccine batches manufactured. At the same time, the Cantacuzino Institute informed the NAMMD about initiation of the procedure for discontinued use of the 7 batches affected in view of recall.
The NAMMD provided prompt reply to the Cantacuzino Institute concerning measures required under such circumstances. Such measures mainly involve mandatory NAMMD information on vaccine amounts recalled as compared to those manufactured and distributed, respectively, for each non-compliant batch. At the same time, it is the MAH’s obligation to destroy all amounts recalled, in compliance with legal provisions in the field.
The NAMMD will further monitor outcomes submitted by the Cantacuzino Institute on quantitative composition of influenza vaccine batches.

04.04.2011
NAMMD press release
In response to the TVR3 channel “RIALITI SOC” show, of 9 p.m., Saturday, 2 April 2011, to the attention of the National Television Directorate
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