MHRA-100580-PIP01-22-M02 (update)

Key Facts

Active Substance
Active Substance:
  • CEMIPLIMAB
Invented Name
Libtayo
PIP Number MHRA-100580-PIP01-22-M02 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Concentrate for solution for infusion
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue)
Route(s) of administration
Route(s) of administration:
  • Intravenous use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance opinion date
20/06/2025
Compliance Check Procedure Number
Compliance procedure number
MHRA-100580-PIP01-22-M02-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):CEMIPLIMAB.pdf
Published Date 01/05/2026