EMA/PE/0000242940 - paediatric investigation plan

buloxibutid sodium

Key facts

• Active substance:
  buloxibutid sodium
• Therapeutic area:
  Respiratory, thoracic and mediastinal disorders
• Decision number:
  EMA/PE/0000242940
• PIP number:
  EMA/PE/0000242940
• 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:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  15/05/2025
• Compliance check done:
  Όχι

Decision

EMA/PE/0000242940 : EMA decision of 15 May 2025 on the granting of a product specific waiver for buloxibutid sodium

Adopted Reference Number: EMADOC-1700519818-2116011