EMEA-000160-PIP01-07-M05

Table of contents

Key facts

Invented name
  • Prepandrix
  • Adjupanrix
Active substance
  • Purified antigen fractions of inactivated split virion Influenza A/Vietnam/1194/2004 (H5N1) like strain used (NIBRG-14)
  • 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/0299/2019
PIP number
EMEA-000160-PIP01-07-M05
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.

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
Compliance procedure number
EMEA-C-000160-PIP01-07-M05
Compliance opinion date
31/01/2020
Compliance outcome
positive

Decision

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