MHRA-100125-PIP01-21

Key Facts

PIPS 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

PIPS Decision Documents
Decision Document Decision Document on a Paediatric Investigation Plan (PIP):PEMBROLIZUMAB;vibostolimab.pdf
Published Date 27/09/2022