Insulin glargine - paediatric investigation plan

insulin glargine

Key facts

• Invented name:
  • Optisulin
  • Toujeo (previously Optisulin)
• Active substance:
  insulin glargine
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/136/2009
• PIP number:
  Insulin glargine
• Pharmaceutical form(s):
  • Solution for injection
  • Solution for injection in a vial
  • Solution for injection in a cartridge
• Condition(s) / indication(s):
  • Treatment of type I diabetes mellitus
  • Treatment of type II diabetes mellitus
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  15/07/2009
• Compliance check done:
  Igen
• Compliance procedure number:
  EMEA-C-000396-PIP01-08
• Compliance opinion date:
  18/11/2011
• Compliance outcome:
  Positive

Decision

P/136/2009: European Medicines Agency decision of 15 July 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a waiver for insulin glargine (Optisulin) (EMEA-000396-PIP01-08) in accordance wi...

Adopted Reference Number: EMEA/387961/2009