EMA/PE/0000238063 - paediatric investigation plan

taladegib

Key facts

• Active substance:
  taladegib
• Therapeutic area:
  Respiratory, thoracic and mediastinal disorders
• Decision number:
  EMA/PE/0000238063
• PIP number:
  EMA/PE/0000238063
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of idiopathic pulmonary fibrosis
• Route(s) of administration:
  All routes of administration
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/04/2025
• Compliance check done:
  Nej

Decision

EMA/PE/0000238063 : EMA decision of 14 April 2025 on the granting of a product specific waiver for taladegib

Adopted Reference Number: EMADOC-1700519818-2035642