EMA/PE/0000223523 - paediatric investigation plan

paltusotine

Key facts

• Active substance:
  paltusotine
• Therapeutic area:
  Endocrine disorders
• Decision number:
  EMA/PE/0000223523
• PIP number:
  EMA/PE/0000223523
• Pharmaceutical form(s):
  Coated tablet
• Condition(s) / indication(s):
  Treatment of acromegaly and pituitary gigantism
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  28/01/2025
• Compliance check done:
  No

Decision

EMA/PE/0000223523 : EMA decision of 28 January 2025 on the granting of a product specific waiver for paltusotine

Adopted Reference Number: EMADOC-1700519818-1840303