EMEA-001495-PIP02-21 - paediatric investigation plan

drospirenone

Key facts

• Active Substance:
  drospirenone
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0451/2021
• PIP number:
  EMEA-001495-PIP02-21
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of endometriosis
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  29/10/2021

Decision

P/0450/2021 : EMA decision of 29 October 2021 on the granting of a product specific waiver for drospirenone (Slinda and associated names), (EMEA- 001495-PIP02-21)

AdoptedReference Number: EMA/533719/2021