The marketing authorisation for Optaflu \[influenza vaccine (surface antigen, inactivated, prepared in cell cultures)\] expired on 5 June 2017 following the decision of the marketing authorisation holder, Seqirus GmbH, not to apply for a renewal of the marketing authorisation. Seqirus GmbH confirmed that it did not apply for renewal of the authorisation due to commercial reasons. Optaflu was granted marketing authorisation in the European Union (EU) on 1 June 2007 for prophylaxis of influenza for adults. The marketing authorisation was valid for a 5\-year period. It was subsequently renewed for an additional 5\-year period in 2012\. The European Public Assessment Report (EPAR) for Optaflu is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.
Therapeutic Indication
Prophylaxis of influenza for adults, especially in those who run an increased risk of associated complications. Optaflu should be used in accordance to official guidance.
Therapeutic Area (MeSH)
ATC Code
J07BB02
ATC Item
N/A
Pharmacotherapeutic Group
Vaccines
Active Substance (Summary)
INN / Common Names
EMA Name
Optaflu
Medicine Name
Optaflu
Aliases
N/ANo risk management plan link.