MHRA-100442-PIP01-22-M02 (update)

Key Facts

Active Substance
Active Substance:
  • TALIMOGENE LAHERPAREPVEC
Invented Name
  • Imlygic
  • Imlygic
  • Imlygic
PIP Number MHRA-100442-PIP01-22-M02 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Treatment of melanoma
Route(s) of administration
Route(s) of administration:
  • INTRALESIONAL
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
28/03/2024
Compliance Check Procedure Number
Compliance procedure number
MHRA-100442-PIP01-22-M02-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):TALIMOGENE LAHERPAREPVEC.pdf
Published Date 30/04/2024