EMEA-003183-PIP02-22 - paediatric investigation plan

exanatide

Key facts

• Active Substance:
  exanatide
• Therapeutic area:
  Neurology
• Decision number:
  P/0475/2022
• PIP number:
  EMEA-003183-PIP02-22
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  Treatment of idiopathic intracranial hypertension
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Invex 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:
  01/12/2022

Decision

P/0475/2022: EMA decision of 1 December 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for exenatide (acetate), (EMEA-003183-PIP02-22)

AdoptedReference Number: EMA/898079/2022