MHRA-101352-PIP01-24-M01 (update)

Key Facts

Active Substance
Active Substance:
  • Autologous tumour-infiltrating lymphocytes (LN-144/LN-145)
Invented Name
  • AMTAGVI
  • AMTAGVI
PIP Number MHRA-101352-PIP01-24-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Dispersion of 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 neoplasms)
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 Check Procedure Number
Compliance procedure number
MHRA-101352-PIP01-24-M01-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Autologous tumour-infiltrating lymphocytes (LN-144/LN-145).pdf
Published Date 24/06/2024