CHMP adopts a positive opinion for change to the marketing authorisation for zoonotic influenza vaccine Seqirus (Aflunov) – CSL

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the marketing authorisation for Zoonotic Influenza Vaccine Seqirus.

The marketing authorisation holder for this medicinal product is Seqirus S.r.l. The CHMP adopted an extension to the existing indication to include active immunisation of children from 6 months of age. For information, the full indication will be as follows: Zoonotic Influenza Vaccine Seqirus H5N8 is indicated for active immunisation against H5 subtype influenza A viruses in individuals 6 months of age and above.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.