EMEA-002700-PIP01-19 - paediatric investigation plan

Crinecerfont

Key facts

• Active Substance:
  Crinecerfont
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0104/2021
• PIP number:
  EMEA-002700-PIP01-19
• Pharmaceutical form(s):
  • Capsule (hard)
  • Oral solution
• Condition(s) / indication(s):
  • Treatment of atypical haemolytic uremic syndrome
  • Treatment of paroxysmal nocturnal haemoglobinuria
• Route(s) of administration:
  • Subcutaneous use
  • Intravenous use
• Contact for public enquiries:

  Neurocrine Therapeutics Ltd

  E-mail: [e-mail]; Tel. [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  17/03/2021
• Compliance opinion date:
  20/09/2019
• Compliance outcome:
  Positive

Decision

P/0104/2021: EMA decision of 17 March 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral for crinecerfont (EMEA-002700-PIP01-19)

AdoptedReference Number: EMA/146014/2021