EMEA-000456-PIP01-08-M02

Key facts

Invented name
Tresiba
Active substance
insulin degludec
Therapeutic area
Endocrinology, -gynacology-fertility-metabolism
Decision number
P/0129/2014
PIP number
EMEA-000456-PIP01-08-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
Contact for public enquiries
Novo Nordisk A/S
Denmark
E-mail: jamp@novonordisk.com
Tel. +45 3075 3759
Fax +45 3969 9173
Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-000456-PIP01-08-M02
Compliance opinion date
23/05/2014
Compliance outcome
positive

Decision

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