MHRA-100254-PIP01-21-M02 (update)

Key Facts

Active Substance
Active Substance:
  • epcoritamab
Invented Name
  • Tepkinly
  • Tepkinly
  • Tepkinly
  • Tepkinly
  • Tepkinly
PIP Number MHRA-100254-PIP01-21-M02 (update)
Pharmaceutical form(s)
  • Concentrate for solution for injection
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Treatment of mature B-cell lymphoma
Route(s) of administration
Route(s) of administration:
  • Subcutaneous use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
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):EPCORITAMAB.pdf
Published Date 29/11/2024