EMEA-000412-PIP01-08-M01 - paediatric investigation plan

Insulin detemir

Key facts

• Invented name:
  • Levemir
  • Levemir
• Active substance:
  Insulin detemir
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0172/2014
• PIP number:
  EMEA-000412-PIP01-08-M01
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  • Treatment of type II diabetes mellitus
  • Treatment of type I diabetes mellitus
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  11/07/2014
• Compliance check done:
  Igen
• Compliance procedure number:
  EMEA-000412-PIP01-08-M01
• Compliance opinion date:
  14/11/2014
• Compliance outcome:
  Positive

Decision

P/0172/2014: EMA decision of 11 July 2014 on the acceptance of a modification of an agreed paediatric investigation plan for insulin detemir (Levemir), (EMEA-000412-PIP01-08-M01)

Adopted Reference Number: EMA/314402/2014