MHRA-100678-PIP01-22-M01 (update)

Key Facts

Active Substance
Active Substance:
  • vamikibart
Invented Name
Not yet available
PIP Number MHRA-100678-PIP01-22-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Ophthamology
Conditions / Indications
Conditions / Indications:
  • Treatment of uveitic macular oedema
Route(s) of administration
Route(s) of administration:
  • Intravitreal use
PIP applicant
  • Roche Products Limited
  • Country United Kingdom
  • Tel 07733208074
  • Email uk.dra@roche.com
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):vamikibart.pdf
Published Date 15/08/2024