EMEA-001559-PIP01-13 - paediatric investigation plan

Pandemic live attenuated influenza virus (H5N1)

Key facts

• Active Substance:
  Pandemic live attenuated influenza virus (H5N1)
• Therapeutic area:
  Vaccines
• Decision number:
  P/0313/2014
• PIP number:
  EMEA-001559-PIP01-13
• Pharmaceutical form(s):
  • Nasal spray
  • Suspension
• Condition(s) / indication(s):
  Prevention of influenza infection
• Route(s) of administration:
  Nasal use
• Contact for public enquiries:

  MedImmune Limited

  United Kingdom ; E-mail: [e-mail] ; Tel. [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  26/11/2014

Decision

P/0313/2014: EMA decision of 26 November 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for pandemic live attenuated influenza virus (H5N1) (EME...

AdoptedReference Number: EMA/667770/2014