EMEA-003059-PIP02-23 - paediatric investigation plan

cagrilintide

semaglutide

Key facts

• Active substance:
  • cagrilintide
  • semaglutide
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0307/2023
• PIP number:
  EMEA-003059-PIP02-23
• Pharmaceutical form(s):
  Solution for injection
• 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:
  04/08/2023
• Compliance check done:
  No

Decision

P/0307/2023 : EMA decision of 4 August 2023 on the granting of a product specific waiver for cagrilintide / semaglutide (EMEA-003059-PIP02-23)

Reference Number: EMA/338964/2023