EMEA-001513-PIP01-13 - paediatric investigation plan

Estetrol

levonorgestrel

Key facts

• Active substance:
  • Estetrol
  • levonorgestrel
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0317/2013
• PIP number:
  EMEA-001513-PIP01-13
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Prevention of pregnancy
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  19/12/2013
• Compliance check done:
  No

Decision

P/0317/2013: EMA decision of 19 December 2013 on the agreement of a paediatric investigation plan and on the granting of a waiver for estetrol / levonorgestrel (EMEA-001513-PIP01-13)

Adopted Reference Number: EMA/725501/2013