To the attention of interested persons
For proper information of the media and the public, following press suppositions concerning immunisation with HEXAXIM, the National Agency for Medicines and Medical Devices declares the following:
HEXAXIM was authorised on 21 June 2012, according to provisions of Article 58 of Regulation (EC) no. 726/2004, following the same qualitative and quantitative assessment procedures as for HEXACIMA. The two products are owned by the same Marketing Authorisation Holder, and the European Medicines Agency warrants the equivalence of standards for assessment of respective documentation for authorisation.
Given the discontinuation of supply with HEXACIMA, Romania, as well as other EU member states, such as Belgium or Poland, has authorised HEXAXIM, by the same manufacturer, in accordance with legislation on marketing authorisation of medicinal products for special needs.
Similarly to all vaccines, in accordance with EU administrative procedure for official batch release, HEXAXIM as well is marketed only after prior batch-by-batch testing.
As regards press assumptions concerning potential association of cases of Haemolytic-Uremic Syndrome (HUS) and administration of HEXAXIM, please note that, in accordance with available records, not any of the children diagnosed with HUS has received a HEXAXIM vaccine.