EMEA-001609-PIP01-14 - paediatric investigation plan

norovirus GI.1 virus-like particle antigen

norovirus GII.4 virus-like particle antigen

Key facts

• Active substance:
  • norovirus GI.1 virus-like particle antigen
  • norovirus GII.4 virus-like particle antigen
• Therapeutic area:
  Vaccines
• Decision number:
  P/0125/2015
• PIP number:
  EMEA-001609-PIP01-14
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  Prevention of acute norovirus gastroenteritis
• Route(s) of administration:
  Intramuscular use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  05/06/2015
• Compliance check done:
  No

Decision

P/0125/2015: EMA decision of 5 June 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for Norovirus GI.1 virus-like particle antigen / Norovirus GI...

Adopted Reference Number: EMA/284196/2015