EMEA-000249-PIP01-10 - paediatric investigation plan

Influenza Virus Type A, H3N2Influenza Virus Type A, H1N1Influenza Virus Type B

Key facts

• Invented name:
  • Fluenz
  • Fluenz
• Active substance:
  Influenza Virus Type A, H3N2Influenza Virus Type A, H1N1Influenza Virus Type B
• Therapeutic area:
  Vaccines
• Decision number:
  P/14/2011
• PIP number:
  EMEA-000249-PIP01-10
• Pharmaceutical form(s):
  Nasal spray suspension
• Condition(s) / indication(s):
  Prevention of influenza infection
• Route(s) of administration:
  Intranasal use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  03/01/2011
• Compliance check done:
  No

Decision

P/14/2011: EMA decision of 3 January 2011 on the review of a granted waiver for influenza virus type A, H3N2, influenza virus type A, H1N1, influenza virus type B (Fluenz) (EMEA-000249-PIP01-10)

Adopted Reference Number: EMA/717956/2010