EMEA-002229-PIP02-21 - paediatric investigation plan

Dienogest

ethinylestradiol

Key facts

• Active Substance:
  • Dienogest
  • ethinylestradiol
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0031/2022
• PIP number:
  EMEA-002229-PIP02-21
• Pharmaceutical form(s):
  Prolonged-release tablet
• Condition(s) / indication(s):
  Treatment of hirsutism associated with polycystic ovary syndrome
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Chemo Research S.L.

  [e-mail]

  [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  31/01/2022

Decision

P/0031/2022: EMA of 31 January 2022 on the agreement of a paediatric investigation plan and on the granting of a waiver for dienogest / ethinylestradiol (EMEA-002229-PIP02-21)

AdoptedReference Number: EMA/11737/2022