LEVEMIR Solution for injection Ref.[8427] Active ingredients: Insulin detemir

Source: European Medicines Agency (EU)  Revision Year: 2018  Publisher: Novo Nordisk A/S, Novo Allé, DK-2880, Bagsværd, Denmark

Product name and form

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.

Qualitative and quantitative composition

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
Phenol
Metacresol
Zinc acetate
Disodium phosphate dihydrate
Sodium chloride
Hydrochloric acid (for pH adjustment)
Sodium hydroxide (for pH adjustment)
Water for injections

Pack sizes and marketing

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.

Marketing authorization holder

Novo Nordisk A/S, Novo Allé, DK-2880, Bagsværd, Denmark

Marketing authorization dates and numbers

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

Drugs

Drug Countries
LEVEMIR Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

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