EMEA-001332-PIP01-12-M06 - paediatric investigation plan

Estetrol

drospirenone

Key facts

• Invented name:
  Lydisilka
• Active substance:
  • Estetrol
  • drospirenone
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0071/2023
• PIP number:
  EMEA-001332-PIP01-12-M06
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Prevention of pregnancy
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  31/12/2021
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-001332-PIP01-12-M06
• Compliance opinion date:
  26/07/2024
• Compliance outcome:
  Positive

Decision

P/0071/2023 : EMA decision of 10 March 2023 on the acceptance of a modification of an agreed paediatric investigation plan for estetrol / drospirenone (Lydisilka, Drovelis and associated names), (EMEA-001332-PIP01-12-M06)

Adopted Reference Number: EMA/85010/2023