MHRA-100136-PIP01-21

Key Facts

Active Substance
  • PEMBROLIZUMAB
  • quavonlimab
Invented Name
Not yet available
PIP Number MHRA-100136-PIP01-21
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Concentrate for solution for infusion
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
Conditions / Indications:
  • All conditions of malignant neoplasms (except haematopoietic, lymphoid tissue and melanoma).
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):PEMBROLIZUMAB;quavonlimab.pdf
Published Date 27/09/2022