EMA’s CHMP Recommends Aujemflu for Influenza Prevention in Adults Aged 50 and Older – Seqirus

According to the CHMP/EMA website, the Committee for Medicinal Products for Human Use 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.