MHRA-100125-PIP01-21

Key Facts

Active Substance
  • PEMBROLIZUMAB
  • vibostolimab
Invented Name
Not yet available
PIP Number MHRA-100125-PIP01-21
Pharmaceutical form(s)
  • Concentrate for solution for infusion
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
  • Malignant neoplasms (except CNS, haematopoietic, lymphoid tissue melanoma)
  • Malignant CNS 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):PEMBROLIZUMAB;vibostolimab.pdf
Published Date 27/09/2022