EMEA-000160-PIP01-07-M05 - paediatric investigation plan

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)

Key facts

• Invented name:
  • • Adjupanrix
    • Prepandrix
  • Prepandrix
• 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: [e-mail]; Tel.: [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/08/2019
• Compliance procedure number:
  EMEA-C-000160-PIP01-07-M05
• Compliance opinion date:
  31/01/2020
• Compliance outcome:
  Positive

Decision

P/0299/2019: European medicines agency decision of 14 August 2019 on the acceptance of a modification of an agreed paediatric investigation plan for purified antigen fractions of inactivated split virion Influenza A/Vietnam/1194/2004 (H5N1)...

AdoptedReference Number: EMA/444271/2019