CHMP positive for Zoonotic Influenza Vaccine Seqirus against H5N1 subtype of Influenza A virus
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Zoonotic Influenza Vaccine Seqirus, intended for the active immunisation against H5N1 subtype of Influenza A virus.
The applicant for this medicinal product is Seqirus S.r.l. Zoonotic Influenza Vaccine Seqirus will be available as a 7.5 mg/0.5 ml suspension for injection. The active substance of Zoonotic Influenza Vaccine Seqirus is zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted), an influenza vaccine (ATC code: J07BB02) that induces an immune response (circulating antibodies) against H5N1 antigens.
The application for Zoonotic Influenza Vaccine Seqirus was an informed consent application. In an informed consent application, reference is made to an authorised medicine where the marketing authorisation holder of the reference medicine has given consent to the use of their dossier in the application procedure. The reference product for Zoonotic Influenza Vaccine Seqirus is Aflunov.
Zoonotic influenza vaccines are intended for immunisation during outbreaks of influenza coming from animals, including when public health authorities anticipate a possible pandemic caused by the virus strain or a similar strain.
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