EMEA-001159-PIP02-12 - paediatric investigation plan

misoprostol

Key facts

• Active substance:
  misoprostol
• Therapeutic area:
  Other
• Decision number:
  P/0163/2012
• PIP number:
  EMEA-001159-PIP02-12
• Pharmaceutical form(s):
  Vaginal delivery system
• Condition(s) / indication(s):
  Induction of labour
• Route(s) of administration:
  Vaginal use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  23/07/2012
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-001159-PIP02-12
• Compliance opinion date:
  11/10/2012
• Compliance outcome:
  Positive

Decision

P/0163/2012: EMA decision of 23 July 2012 on the agreement of a paediatric investigation plan and on the granting of a waiver for misoprostol (EMEA-001159-PIP02-12)

Adopted Reference Number: EMA/475432/2012