ABASAGLAR Solution for injection Ref.[116217] Active ingredients: Insulin glargine

Source: European Medicines Agency (EU)  Revision Year: 2026  Publisher: Eli Lilly Nederland B.V., Orteliuslaan 1000, 3528 BD Utrecht, The Netherlands

Product name and form

ABASAGLAR 100 units/mL solution for injection in a cartridge.

Pharmaceutical Form

Solution for injection (injection).

Clear, colourless solution.

Qualitative and quantitative composition

Each mL contains 100 units insulin glargine* (equivalent to 3.64 mg).

Each cartridge contains 3 mL of solution for injection, equivalent to 300 units.

* produced by recombinant DNA technology in Escherichia coli.

For the full list of excipients, see section 6.1.

Active Ingredient

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

Pack sizes and marketing

3 mL solution in a cartridge (type 1 colourless glass) with a plunger (halobutyl rubber) and a disc seal (laminate of polyisoprene and halobutyl rubber) with aluminium seal.

Packs of 5 and 10 cartridges. Not all pack sizes may be marketed.

Marketing authorization holder

Eli Lilly Nederland B.V., Orteliuslaan 1000, 3528 BD Utrecht, The Netherlands

Marketing authorization dates and numbers

EU/1/14/944/003
EU/1/14/944/009

Date of first authorisation: 9 September 2014
Date of latest renewal: 25 July 2019

Drugs

Drug Countries
ABASAGLAR Austria, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Lithuania, Netherlands, Poland, Romania, United Kingdom

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