TOUJEO Solution for injection Ref.[7286] Active ingredients: Insulin glargine

Source: European Medicines Agency (EU)  Revision Year: 2023  Publisher: Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany

Product name and form

Toujeo 300 units/ml SoloStar, solution for injection in a pre-filled pen.

Toujeo 300 units/ml DoubleStar, solution for injection in a pre-filled pen.

Pharmaceutical Form

Solution for injection (injection).

Clear colourless solution.

Qualitative and quantitative composition

Each ml contains 300 units insulin glargine* (equivalent to 10.91 mg).

SoloStar pen: Each pen contains 1.5 ml of solution for injection, equivalent to 450 units.

DoubleStar pen: Each pen contains 3 ml of solution for injection, equivalent to 900 units.

* Insulin glargine is produced by recombinant DNA technology in Escherichia coli.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Insulin glargine

Insulin glargine is a human insulin analogue designed to have a low solubility at neutral pH. After injection, the acidic solution is neutralised leading to formation of a precipitate from which small amounts of insulin glargine are continuously released.

List of Excipients

Zinc chloride
Metacresol
Glycerol
Hydrochloric acid (for pH adjustment)
Sodium hydroxide (for pH adjustment)
Water for injections

Pack sizes and marketing

SoloStar pen

Cartridge (type 1 colourless glass) with a grey plunger (bromobutyl rubber) and a flanged cap (aluminium) with a stopper (laminate of isoprene and bromobutyl rubber).The cartridge is sealed in a disposable pen injector. Each cartridge contains 1.5 ml solution.

Packs of 1, 3, 5 and 10 pens are available. Not all pack sizes may be marketed.

Needles are not included in the pack.

DoubleStar pen

Cartridge (type 1 colourless glass) with a black plunger (bromobutyl rubber) and a flanged cap (aluminium) with a stopper (laminate of isoprene and bromobutyl rubber).The cartridge is sealed in a disposable pen injector. Each cartridge contains 3 ml solution.

Packs of 1, 3, 6 (2 packs of 3), 9 (3 packs of 3) and 10 pens are available. Not all pack sizes may be marketed.

Needles are not included in the pack.

Marketing authorization holder

Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany

Marketing authorization dates and numbers

EU/1/00/133/033
EU/1/00/133/034
EU/1/00/133/035
EU/1/00/133/036
EU/1/00/133/037
EU/1/00/133/038
EU/1/00/133/039
EU/1/00/133/040
EU/1/00/133/041

Date of first authorisation: 27 June 2000
Date of latest renewal: 17 February 2015

Drugs

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

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