EMEA-000687-PIP01-09-M02

Key facts

Invented name
Arepanrix
Active substance
Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted), containing antigen equivalent to Influenza A/California/7/2009 (Produced at Quebec manufacturing site)
Therapeutic area
Vaccines
Decision number
P/148/2010
PIP number
EMEA-000687-PIP01-09-M02
Pharmaceutical form(s)
Suspension and emulsion for emulsion for injection
Condition(s) / indication(s)
Influenza
Route(s) of administration
Intramuscular use
Contact for public enquiries
GlaxoSmithKline Biologicals S.A. (UK)

eu.paediatric-plans@gsk.com
Country: United Kingdom
Phone: +44 2089663220
Fax: +44 2089662221

 

Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-000687-PIP01-09-M02
Compliance opinion date
12/12/2014
Compliance outcome
positive

Decision

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