EMEA-002428-PIP02-18 - paediatric investigation plan

relugolix

estradiol

norethisterone acetate

Key facts

• Active substance:
  • relugolix
  • estradiol
  • norethisterone acetate
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0278/2019
• PIP number:
  EMEA-002428-PIP02-18
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of endometriosis
• Route(s) of administration:
  Oral use
• Decision type:
  RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
• Decision date:
  16/08/2019
• Compliance check done:
  No

Decision

P/0278/2019: EMA decision of 16 August 2019 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of a waiver for relugolix / estradiol / norethisterone acetate (EMEA-002428-PIP02-18)

Adopted Reference Number: EMA/444283/2019