EMEA-000306-PIP01-08-M04 - paediatric investigation plan

corifollitropin alfa

Key facts

• Invented name:
  Elonva
• Active substance:
  corifollitropin alfa
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0143/2019
• PIP number:
  EMEA-000306-PIP01-08-M04
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of hypogonadotrophic hypogonadism
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  17/04/2019
• Compliance check done:
  Igen
• Compliance procedure number:
  EMEA-C-000306-PIP01-08-M04
• Compliance opinion date:
  29/01/2021
• Compliance outcome:
  Positive

Decision

P/0143/2019: EMA decision of 17 April 2019 on the acceptance of a modification of an agreed paediatric investigation plan for corifollitropin alfa (Elonva), (EMEA-000306-PIP01-08-M04)

Adopted Reference Number: EMA/215937/2019