EMEA-000687-PIP01-09-M02 - paediatric investigation plan

Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted), containing antigen equivalent to Influenza A/California/7/2009
PIPHuman

Key facts

Invented name
  • Arepanrix
  • Arepanrix
Active Substance
Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted), containing antigen equivalent to Influenza A/California/7/2009
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)

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

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

Decision

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