EMEA-003406-PIP01-23 - paediatric investigation plan

opicapone

Key facts

• Invented name:
  • Ongentys
  • Ontilyv
• Active substance:
  opicapone
• Therapeutic area:
  Neurology
• Decision number:
  P/0260/2023
• PIP number:
  EMEA-003406-PIP01-23
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Treatment of Parkinson's disease
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  14/07/2023
• Compliance check done:
  Nej

Decision

P/0260/2023 : EMA decision of 14 July 2023 on the granting of a product specific waiver for opicapone (Ongentys, Ontilyv), (EMEA-003406-PIP01- 23)

Reference Number: EMA/284059/2023