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
Yes
Compliance Check Decision Date
Compliance opinion date
18/08/2026
Compliance Check Procedure Number
Compliance procedure number
MHRA-100254-PIP01-21-M02-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):EPCORITAMAB.pdf
Published Date 14/10/2026