EMEA-003166-PIP01-21 - paediatric investigation plan

Insulin lispro (BC222)

Key facts

• Active substance:
  Insulin lispro (BC222)
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0064/2023
• PIP number:
  EMEA-003166-PIP01-21
• Pharmaceutical form(s):
  Solution for injection/infusion
• Condition(s) / indication(s):
  Treatment of type 1 diabetes mellitus / Treatment of type 2 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:
  10/03/2023
• Compliance check done:
  No

Decision

P/0064/2023 : EMA decision of 10 March 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for insulin lispro (BC222), (EMEA-003166-PIP01-21)

Reference Number: EMA/77087/2023