EMEA-000124-PIP01-07-M02

Key facts

Invented name
Optaflu
Active substance
Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains: A/Solomon Islands/3/2006 (H1N1)-like strain (A/Solomon Islands/3/2006, IVR-145); A/Wisconsin/67/2005 (H3N2)-like strain (A/Wisconsin/67/2005, NYMC X161B); B/Malaysia/2506/2004-like strain (B/Malaysia/2506/2004)
Therapeutic area
Vaccines
Decision number
P/0210/2012
PIP number
EMEA-000124-PIP01-07-M02
Pharmaceutical form(s)
Suspension for injection (in a pre-filled syringe)
Condition(s) / indication(s)
Prevention of influenza
Route(s) of administration
Intramuscular use
Contact for public enquiries
Novartis Vaccines & Diagnostics GmbH & Co. KG
Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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