Aujemflu

Opinion

EMA has issued an opinion on this medicine

Influenza vaccine (surface antigen, inactivated, adjuvanted, prepared in cell culture)

Overview

On 25 June 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Aujemflu, intended for the prevention of influenza in people 50 years of age and older.

The applicant for this medicinal product is Seqirus Netherlands B.V.

Aujemflu will be available as a suspension for injection in pre-filled syringes. Aujemflu is an influenza vaccine (ATC code: J07BB02). It contains haemagglutinin and neuraminidase surface antigens from 3 inactivated influenza virus strains, two A subtypes (H1N1 and H3N2) and a B type (Victoria lineage). Aujemflu provides protection against the influenza viruses it targets by inducing neutralising antibodies against viral haemagglutinin.

The benefit of Aujemflu is the induction of an immune response that is non-inferior to that achieved with other authorised influenza vaccines. The most common side effects with Aujemflu are injection site pain, fatigue, headache, arthralgia and myalgia.

The full indication is:

Prophylaxis of influenza in adults 50 years of age and older. 

Aujemflu should be used in accordance with official recommendations.

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

CHMP summary of positive opinion for Aujemflu

Adopted Reference Number: EMADOC-1829012207-56091

Product details

• Name of medicine:
  Aujemflu
• Active substance:
  Influenza virus surface antigens (haemagglutinin and neuraminidase) of the following strains: A/(H1N1), A/(H3N2), B/Yamagata lineage, B/Victoria lineage
• International non-proprietary name (INN) or common name:
  Influenza vaccine (surface antigen, inactivated, adjuvanted, prepared in cell culture)
• Therapeutic area (MeSH):
  Influenza, Human
• Anatomical therapeutic chemical (ATC) code:
  J07BB02
• EMA product number:
  EMEA/H/C/006692
• Marketing authorisation applicant:
  Seqirus Netherlands B.V.
• Opinion adopted:
  25/06/2026
• Opinion status:
  Positive