EMEA-003384-PIP02-23 - paediatric investigation plan

levodopa

carbidopa monohydrate

Key facts

• Active substance:
  • levodopa
  • carbidopa monohydrate
• Therapeutic area:
  Neurology
• Decision number:
  P/0220/2023
• PIP number:
  EMEA-003384-PIP02-23
• Pharmaceutical form(s):
  Concentrate and solvent for solution for infusion
• Condition(s) / indication(s):
  Treatment of Parkinson's disease
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  14/06/2023
• Compliance check done:
  No

Decision

P/0220/2023 : EMA decision of 14 June 2023 on the granting of a product specific waiver for levodopa / carbidopa monohydrate (EMEA-003384- PIP02-23)

Reference Number: EMA/236617/2023