EMEA-002229-PIP02-21-M01 - paediatric investigation plan

Dienogest

ethinylestradiol

Key facts

• Active Substance:
  • Dienogest
  • ethinylestradiol
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0217/2023
• PIP number:
  EMEA-002229-PIP02-21-M01
• 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: [e-mail] ; Tel.: [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/06/2023

Decision

P/0217/2023 : EMA decision of 14 June 2023 on the acceptance of a modification of an agreed paediatric investigation plan for dienogest / ethinylestradiol (EMEA-002229-PIP02-21-M01)

Reference Number: EMA/238158/2023