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.