EMEA-001556-PIP01-13 - paediatric investigation plan

Human recombinant interleukin-2

Key facts

• Active substance:
  Human recombinant interleukin-2
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0097/2015
• PIP number:
  EMEA-001556-PIP01-13
• Pharmaceutical form(s):
  Powder for solution for injection
• Condition(s) / indication(s):
  Treatment of type I diabetes mellitus
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  08/05/2015
• Compliance check done:
  Nem

Decision

P/0097/2015: EMA decision of 8 May 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for human recombinant interleukin-2 (EMEA-001556-PIP01-13)

Reference Number: EMA/281879/2015