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Pandemrix

Active Substance: split influenza virus inactivated, containing antigen equivalent to A/California/07/2009 (H1N1)-derived strain used NYMC X-179A
Common Name: influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted) A/California/7/2009 (H1N1)v like strain (x-179a)
ATC Code: J07BB02
Marketing Authorisation Holder: GlaxoSmithKline Biologicals S.A.
Active Substance: split influenza virus inactivated, containing antigen equivalent to A/California/07/2009 (H1N1)-derived strain used NYMC X-179A
Status: Withdrawn
Authorisation Date: 2008-05-20
Therapeutic Area: Influenza, Human Immunization Disease Outbreaks
Pharmacotherapeutic Group: Influenza vaccines

Therapeutic Indication

Prophylaxis of influenza caused by A (H1N1)v 2009 virus. Pandemrix should only be used if the recommended annual seasonal trivalent / quadrivalent influenza vaccines are not available and if immunisation against (H1N1)v is considered necessary (see sections 4.4 and 4.8).

Pandemrix should be used in accordance with Official Guidance.

The marketing authorisation for Pandemrix has expired following the marketing-authorisation holder’s decision not to apply for a renewal.

Source: European Medicines Agency

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