MHRA-100678-PIP01-22

Key Facts

Active Substance
Active Substance:
  • Humanised IgG2 monoclonal antibody against interleukin-6 (RO7200220)
Invented Name
Not available at present
PIP Number MHRA-100678-PIP01-22
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
Decision Type
Decision Type
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
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):Humanised IgG2 monoclonal antibody against interleukin-6 (RO7200220).pdf
Published Date 19/12/2023