EMEA-003105-PIP01-21 - paediatric investigation plan

Insulin efsitora alfa

Key facts

• Active Substance:
  Insulin efsitora alfa
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0034/2022
• PIP number:
  EMEA-003105-PIP01-21
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  • Type 1 diabetes mellitus
  • Type 2 diabetes mellitus
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Eli Lilly and Company Ltd

  E-mail: [e-mail]; Phone: [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  04/02/2022

Decision

P/0034/2022 : EMA decision of 4 February 2022 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of a waiver for insulin efsitora alfa (EMEA-003105-PIP01-21)

AdoptedReference Number: P/0034/2022