MHRA-101857-PIP01-25

Key Facts

Active Substance
Active Substance:
  • Humanised afucosylated IgG1 monoclonal antibody against CCR8
Invented Name
Not yet available
PIP Number MHRA-101857-PIP01-25
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Treatment of all conditions included in the category of malignant neoplasms except melanoma, nervous system neoplasms, haematopoietic and lymphoid tissue neoplasms
Route(s) of administration
  • Intravenous use
  • SUBCUTANEOUS 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):Humanised afucosylated IgG1 monoclonal antibody against CCR8.pdf
Published Date 29/08/2025