EMEA-000456-PIP01-08-M02 - paediatric investigation plan

insulin degludec

Key facts

• Invented name:
  • Tresiba
  • Tresiba
• Active substance:
  insulin degludec
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0129/2014
• PIP number:
  EMEA-000456-PIP01-08-M02
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  • Treatment of type I diabetes mellitus
  • Treatment of type II diabetes mellitus
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  20/05/2014
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000456-PIP01-08-M02
• Compliance opinion date:
  23/05/2014
• Compliance outcome:
  Positive

Decision

P/0129/2014: EMA decision of 20 May 2014 on the acceptance of a modification of an agreed paediatric investigation plan for insulin degludec (Tresiba), (EMEA-000456-PIP01-08-M02)

Adopted Reference Number: EMA/279156/2014