EMEA-002617-PIP01-19 - paediatric investigation plan

ravagalimab

Key facts

• Active substance:
  ravagalimab
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0241/2020
• PIP number:
  EMEA-002617-PIP01-19
• Pharmaceutical form(s):
  • Solution for injection
  • Solution for infusion
• Condition(s) / indication(s):
  Treatment of ulcerative colitis
• Route(s) of administration:
  • Intravenous use
  • Subcutaneous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  25/06/2020
• Compliance check done:
  Níl

Decision

P/0241/2020: EMA decision of 25 June 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for ravagalimab (EMEA-002617-PIP01-19)

Adopted Reference Number: EMA/317104/2020