EMEA-000411-PIP01-08 - paediatric investigation plan

mifepristone

misoprostol

Key facts

• Active substance:
  • mifepristone
  • misoprostol
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/156/2009
• PIP number:
  EMEA-000411-PIP01-08
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Medical Abortion
• Route(s) of administration:
  • Oral use
  • Vaginal use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  11/08/2009
• Compliance check done:
  No

Decision

P/156/2009: European Medicines Agency decision of 11 August 2009 on the granting of a product specific waiver for Mifepristone / Misoprostol (EMEA-000411-PIP01-08) in accordance with Regulation (EC) No 1901/2006 of the E...

Adopted Reference Number: EMEA/492918/2009