Purified antigen fractions of inactivated split virion Influenza A/Indonesia/5/05 (H5N1) - paediatric investigation plan

purified antigen fractions of inactivated split virion Influenza A/Indonesia/5/05 (H5N1)

Key facts

• Active substance:
  purified antigen fractions of inactivated split virion Influenza A/Indonesia/5/05 (H5N1)
• Therapeutic area:
  Vaccines
• Decision number:
  P/79/2009
• PIP number:
  Purified antigen fractions of inactivated split virion Influenza A/Indonesia/5/05 (H5N1)
• Pharmaceutical form(s):
  Emulsion and suspension for emulsion for injection
• Condition(s) / indication(s):
  Influenza infection caused by an influenza strain contained in the vaccine or related to a strain contained in the vaccine
• Route(s) of administration:
  Intramuscular injection
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  24/04/2009
• Compliance check done:
  No

Decision

P/79/2009: European Medicines Agency decision of 24 April 2009 on the agreement of a Paediatric Investigation Plan and on granting of a deferral and on granting of a waiver for purified antigen fractions of inactivated s...

Adopted Reference Number: EMEA/227977/2009