EMEA-001097-PIP01-10-M02 - paediatric investigation plan

Insulin peglispro

Key facts

• Active Substance:
  Insulin peglispro
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0168/2014
• PIP number:
  EMEA-001097-PIP01-10-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:
  08/07/2014

Decision

P/0168/2014: EMA decision of 8 July 2014 on the acceptance of a modification of an agreed paediatric investigation plan for insulin peglispro (EMEA-001097-PIP01-10-M02)

AdoptedReference Number: EMA/349913/2014