EMEA-000412-PIP01-08-M01

Key facts

Invented name
Levemir
Active substance
Insulin detemir
Therapeutic area
Endocrinology-Gynaecology-Fertility-Metabolism
Decision number
P/0172/2014
PIP number
EMEA-000412-PIP01-08-M01
Pharmaceutical form(s)
Solution for injection
Condition(s) / indication(s)
  • Treatment of type II diabetes mellitus
  • Treatment of type I diabetes mellitus
Route(s) of administration
Subcutaneous use
Contact for public enquiries
Novo Nordisk A/S
Denmark
E-mail: drej@novonordisk.com
Tel. +45 30758086
Fax +45 44436740
Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-000412-PIP01-08-M01
Compliance opinion date
14/11/2014
Compliance outcome
positive

Decision

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