EMEA-001193-PIP01-11 - paediatric investigation plan

insulin degludec

liraglutide

Key facts

• Active Substance:
  • insulin degludec
  • liraglutide
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/310/2011
• PIP number:
  EMEA-001193-PIP01-11
• 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:

  Novo Nordisk A/S

  Denmark ; [e-mail] ; [phone] ; [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  21/12/2011

Decision

P/310/2011: EMA decision of 20 December 2011 on the granting of a product specific waiver for insulin degludec / liraglutide (EMEA-001193-PIP01-11)

AdoptedReference Number: EMA/944182/2011