24.02.2015
To the attention of interested persons
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.