EMEA-002988-PIP01-21 - paediatric investigation plan

Insulin icodec

semaglutide

Key facts

• Active Substance:
  • Insulin icodec
  • semaglutide
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0312/2021
• PIP number:
  EMEA-002988-PIP01-21
• Pharmaceutical form(s):
  Solution for injection in pre-filled pen
• Condition(s) / indication(s):
  Treatment of type II diabetes mellitus
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  11/08/2021

Decision

P/0312/2021 : EMA decision of 11 August 2021 on the granting of a product specific waiver for insulin icodec / semaglutide (EMEA-002988-PIP01-21)

AdoptedReference Number: EMA/434120/2021