EMEA-000178-PIP01-07-M04

Key facts

Invented name
Pumarix
Active substance
Purified antigen fractions of inactivated split virion Influenza A/Indonesia/05/2005(H5N1) like strain used (PR8-IBCDC-RG2)
Therapeutic area
Vaccines
Decision number
P/0088/2015
PIP number
EMEA-000178-PIP01-07-M04
Pharmaceutical form(s)
Emulsion and suspension for emulsion for injection
Condition(s) / indication(s)
Prevention of influenza infection
Route(s) of administration
Intramuscular use
Contact for public enquiries
GlaxoSmithKline Biologicals S.A. (Belgium)

Tel. +1 438 899 8201
Email: eu.paediatric-plans@gsk.com

Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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