EMEA-003540-PIP01-23 - paediatric investigation plan

vixarelimab

Key facts

• Active substance:
  vixarelimab
• Therapeutic area:
  Respiratory, thoracic and mediastinal disorders
• Decision number:
  P/0095/2024
• PIP number:
  EMEA-003540-PIP01-23
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of idiopathic pulmonary fibrosis
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  12/04/2024
• Compliance check done:
  No

Decision

P/0095/2024: EMA decision of 12 April 2024 on the granting of a product specific waiver for vixarelimab (EMEA-003540-PIP01-23)

Adopted Reference Number: EMA/77767/2024