Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Novo Nordisk A/S, Novo Allé, DK-2880, Bagsværd, Denmark
Levemir Penfill 100 units/ml solution for injection in cartridge.
Levemir FlexPen 100 units/ml solution for injection in pre-filled pen.
Levemir InnoLet 100 units/ml solution for injection in pre-filled pen.
Levemir FlexTouch 100 units/ml solution for injection in pre-filled pen.
| Pharmaceutical Form |
|---|
|
Solution for injection. The solution is clear, colourless and aqueous. |
Levemir Penfill: 1 ml of the solution contains 100 units insulin detemir* (equivalent to 14.2 mg). 1 cartridge contains 3 ml equivalent to 300 units.
Levemir FlexPen/Levemir InnoLet/Levemir FlexTouch: 1 ml of the solution contains 100 units insulin detemir* (equivalent to 14.2 mg). 1 pre-filled pen contains 3 ml equivalent to 300 units.
* Insulin detemir is produced in Saccharomyces cerevisiae by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Insulin detemir |
Insulin detemir is a soluble, long-acting insulin analogue with a prolonged duration of effect used as a basal insulin. |
| List of Excipients |
|---|
|
Glycerol |
Levemir Penfill: 3 ml solution in cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene).
Pack sizes of 1, 5 and 10 cartridges. Not all pack sizes may be marketed.
Levemir FlexPen: 3 ml solution in cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polypropylene.
Pack sizes of 1 (with or without needles), 5 (without needles) and 10 (without needles) pre-filled pens. Not all pack sizes may be marketed.
Levemir InnoLet: 3 ml solution in cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polypropylene.
Pack sizes of 1, 5 and 10 pre-filled pens. Not all pack sizes may be marketed.
Levemir FlexTouch: 3 ml solution in cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polypropylene.
Pack sizes of 1 (with or without needles), 5 (without needles) or a multipack with 2 × 5 (without needles) pre-filled pens of 3 ml. Not all pack sizes may be marketed.
Novo Nordisk A/S, Novo Allé, DK-2880, Bagsværd, Denmark
Levemir Penfill:
EU/1/04/278/001
EU/1/04/278/002
EU/1/04/278/003
Levemir FlexPen:
EU/1/04/278/004
EU/1/04/278/005
EU/1/04/278/006
EU/1/04/278/010
EU/1/04/278/011
Levemir InnoLet:
EU/1/04/278/007
EU/1/04/278/008
EU/1/04/278/009
Levemir FlexTouch:
EU/1/04/278/012
EU/1/04/278/013
EU/1/04/278/014
EU/1/04/278/015
EU/1/04/278/016
Date of first authorisation: 01 June 2004
Date of last renewal: 16 April 2009
| Drug | Countries | |
|---|---|---|
| LEVEMIR | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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