MHRA-100874-PIP01-23

Key Facts

Active Substance
Active Substance:
  • PEMBROLIZUMAB
Invented Name
Keytruda
PIP Number MHRA-100874-PIP01-23
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
  • Treatment of all conditions included in the category of malignant neoplasms (except nervous system, haematopoietic and lymphoid tissue)
  • Treatment of Hodgkin lymphoma
Route(s) of administration
Route(s) of administration:
  • 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):PEMBROLIZUMAB.pdf
Published Date 19/12/2023