EMEA-000725-PIP01-09-M03

Key facts

Invented name
Pandemrix
Active substance
Split influenza virus, inactivated, containing antigen: A/California/7/2009 (H1N1)v like strain (X-179A)
Therapeutic area
Vaccines
Decision number
P228/2011
PIP number
EMEA-000725-PIP01-09-M03
Pharmaceutical form(s)
Suspension and emulsion for injection
Condition(s) / indication(s)
Influenza
Route(s) of administration
Intramuscular use
Contact for public enquiries
GlaxoSmithKline Biologicals S.A.
E-mail: rix.eudralink@gskbio.com
Country: Belgium
Phone: +32 10859472
Fax: +32 10858194
Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-000725-PIP01-09-M03
Compliance opinion date
12/12/2014
Compliance outcome
positive

Decision

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