EMEA-003215-PIP01-22 - paediatric investigation plan

Humanised IgG2 monoclonal antibody against interleukin-6 (RO7200220)

Key facts

• Active Substance:
  Humanised IgG2 monoclonal antibody against interleukin-6 (RO7200220)
• Therapeutic area:
  Ophthalmology
• Decision number:
  P/0072/2023
• PIP number:
  EMEA-003215-PIP01-22
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of uveitic macular oedema
• Route(s) of administration:
  Intravitreal use
• Contact for public enquiries:

  Roche Registration GmbH

  E-mail: [e-mail]; Tel. [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  10/03/2023

Decision

P/0072/2023 : EMA decision of 10 March 2023 on the agreement of a paediatric investigation plan and on the granting of a waiver for humanised IgG2 monoclonal antibody against interleukin-6 (RO7200220) (EMEA-003215-PIP01-22)

Reference Number: P/0072/2023