EMA/PE/0000258095 - paediatric investigation plan

levodopa

carbidopa monohydrate

Key facts

• Active substance:
  • levodopa
  • carbidopa monohydrate
• Therapeutic area:
  Nervous system disorders
• Decision number:
  EMA/PE/0000258095
• PIP number:
  EMA/PE/0000258095
• Pharmaceutical form(s):
  Modified release capsule
• 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:
  24/06/2025
• Compliance check done:
  No

Decision

EMA/PE/0000258095 : EMA decision of 24 June 2025 on the granting of a product specific waiver for levodopa / carbidopa (monohydrate)

Adopted Reference Number: EMADOC-1700519818-2232645