EMEA-001137-PIP01-11 - paediatric investigation plan

progesterone

Key facts

• Active substance:
  progesterone
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/150/2011
• PIP number:
  EMEA-001137-PIP01-11
• Pharmaceutical form(s):
  • Solution for injection
  • Powder for solution for injection
• Condition(s) / indication(s):
  • Treatment of female infertility
  • Prevention of recurrent spontaneous abortion
• Route(s) of administration:
  • Subcutaneous use
  • Intramuscular use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  10/06/2011
• Compliance check done:
  No

Decision

P/150/2011: EMA decision of 10 June 2011 on the granting of a product specific waiver for progesterone (EMEA-001137-PIP01-11)

Adopted Reference Number: EMA/387190/2011