EMEA-000915-PIP01-10 - paediatric investigation plan

lixisenatide

insulin glargine

Key facts

• Active Substance:
  • lixisenatide
  • insulin glargine
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/168/2010
• PIP number:
  EMEA-000915-PIP01-10
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of type II diabetes mellitus
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Sanofi-aventis R&D

  [e-mail]; France; [phone]; [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  03/09/2010

Decision

P/168/2010: European Medicines Agency decision of 3 September 2010 on the granting of a product specific waiver for lixisenatide / insulin glargine, (EMEA-000915-PIP01-10)

AdoptedReference Number: EMA/477369/2010