MHRA-101846-PIP01-25

Key Facts

Active Substance
Active Substance:
  • budigalimab
Invented Name
Not available at present
PIP Number MHRA-101846-PIP01-25
Pharmaceutical form(s)
  • Powder for solution for infusion
  • Solution for infusion
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Treatment of all conditions inc. in the category of malignant neoplasms except melanoma, CNS neoplasms, haematopoietic and lymphoid tissues neoplasms
Route(s) of administration
Route(s) of administration:
  • Intravenous use
PIP applicant
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):budigalimab.pdf
Published Date 04/03/2026