MHRA-101789-PIP01-25

Key Facts

Active Substance
Active Substance:
  • Vixarelimab
Invented Name
Not yet available
PIP Number MHRA-101789-PIP01-25
Pharmaceutical form(s)
  • Solution for injection
  • subcutaneous injection
Therapeutic area
Therapeutic area:
  • Pneumology - Allergology
Conditions / Indications
Conditions / Indications:
  • Treatment of idiopathic pulmonary fibrosis (IPF)
Route(s) of administration
Route(s) of administration:
  • Subcutaneous use
PIP applicant
  • Roche Products Limited
  • Country United Kingdom
  • Tel 07467461278
  • Email uk.dra@roche.com
Decision Type
Decision Type
W: decision granting a waiver in all age groups for the listed condition(s).
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP): Vixarelimab.pdf
Published Date 23/06/2025