EMEA-000479-PIP01-08-M03 - paediatric investigation plan

insulin degludec

insulin aspart

Key facts

• Invented name:
  • Ryzodeg
  • Ryzodeg
• Active Substance:
  • insulin degludec
  • insulin aspart
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0034/2015
• PIP number:
  EMEA-000479-PIP01-08-M03
• 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
• Contact for public enquiries:

  Novo Nordisk A/S

  Denmark; Tel. [phone]; Fax [phone]; E-mail: [e-mail]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  06/03/2015
• Compliance procedure number:
  EMEA-C-000479-PIP01-08-M03
• Compliance opinion date:
  11/09/2015
• Compliance outcome:
  Positive

Decision

P/0034/2015: EMA decision of 6 March 2015on the acceptance of a modification of an agreed paediatric investigation plan for insulin degludec / insulin aspart (Ryzodeg), (EMEA-000479-PIP01-08-M03)

AdoptedReference Number: EMA/86543/2015