EMEA-000383-PIP04-23 - paediatric investigation plan

Cladribine

Key facts

• Active substance:
  Cladribine
• Therapeutic area:
  Nervous system disorders
• Decision number:
  P/0009/2024
• PIP number:
  EMEA-000383-PIP04-23
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of myasthenia gravis
• Route(s) of administration:
  All routes of administration
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  31/01/2024
• Compliance check done:
  No

Decision

P/0009/2024 : EMA decision of 31 January 2024 on the granting of a product-specific waiver for cladribine (EMEA-000383-PIP04-23)

Adopted Reference Number: EMA/11057/2024