SAXENDA Solution for injection Ref.[50783] Active ingredients: Liraglutide

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark

Product name and form

Saxenda 6 mg/ml solution for injection in pre-filled pen.

Pharmaceutical Form

Solution for injection.

Clear and colourless or almost colourless, isotonic solution; pH=8.15.

Qualitative and quantitative composition

1 ml of solution contains 6 mg of liraglutide*. One pre-filled pen contains 18 mg liraglutide in 3 ml.

* human glucagon-like peptide-1 (GLP-1) analogue produced by recombinant DNA technology in Saccharomyces cerevisiae.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Liraglutide

Liraglutide is a GLP-1 analogue with 97% sequence homology to human GLP-1 that binds to and activates the GLP-1 receptor. The GLP-1 receptor is the target for native GLP-1, an endogenous incretin hormone that potentiates glucose-dependent insulin secretion from the pancreatic beta cells. Unlike native GLP-1, liraglutide has a pharmacokinetic and pharmacodynamic profile in humans suitable for once daily administration.

List of Excipients

Disodium phosphate dihydrate
Propylene glycol
Phenol
Hydrochloric acid (for pH adjustment)
Sodium hydroxide (for pH adjustment)
Water for injections

Pack sizes and marketing

Cartridge (type 1 glass) with a plunger (bromobutyl) and a laminate rubber sheet (bromobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polypropylene, polyacetal, polycarbonate and acrylonitrile butadiene styrene.

Each pen contains 3 ml solution and is able to deliver doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg and 3.0 mg.

Pack sizes of 1, 3 or 5 pre-filled pens.

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

EU/1/15/992/001-003

Date of first authorisation: 23 March 2015
Date of latest renewal: 09 December 2019

Drugs

Drug Countries
SAXENDA Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States

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