WEGOVY Solution for injection Ref.[49657] Active ingredients: Semaglutide

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

Product name and form

Wegovy 0.25 mg solution for injection in pre-filled pen.
Wegovy 0.5 mg solution for injection in pre-filled pen.
Wegovy 1 mg solution for injection in pre-filled pen.
Wegovy 1.7 mg solution for injection in pre-filled pen.
Wegovy 2.4 mg solution for injection in pre-filled pen.

Pharmaceutical Form

Solution for injection (injection).

Clear and colourless isotonic solution; pH=7.4.

Qualitative and quantitative composition

Wegovy 0.25 mg solution for injection: Each single-use pre-filled pen contains 0.25 mg semaglutide* in 0.5 mL solution. One mL of solution contains 0.5 mg of semaglutide*.

Wegovy 0.5 mg solution for injection: Each single-use pre-filled pen contains 0.5 mg semaglutide* in 0.5 mL solution. One mL of solution contains 1 mg of semaglutide*.

Wegovy 1 mg solution for injection: Each single-use pre-filled pen contains 1 mg semaglutide* in 0.5 mL solution. One mL of solution contains 2 mg of semaglutide*.

Wegovy 1.7 mg solution for injection: Each single-use pre-filled pen contains 1.7 mg semaglutide* in 0.75 mL solution. One mL of solution contains 2.27 mg of semaglutide*.

Wegovy 2.4 mg solution for injection: Each single-use pre-filled pen contains 2.4 mg semaglutide* in 0.75 mL solution. One mL of solution contains 3.2 mg of semaglutide*.

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

For the full list of excipients, see section 6.1.

Active Ingredient Description
Semaglutide

Semaglutide is a GLP-1 receptor agonist. It acts in the same way as GLP-1 (a hormone produced in the gut) by increasing the amount of insulin that the pancreas releases in response to food. This helps with the control of blood glucose levels.

List of Excipients

Disodium phosphate, dihydrate
Sodium chloride
Hydrochloric acid (for pH adjustment)
Sodium hydroxide (for pH adjustment)
Water for injections

Pack sizes and marketing

1 mL glass syringe (type I glass) with attached stainless steel needle, rigid needle shield (type II/polyisoprene) and a rubber plunger (type I/chlorobutyl).

Pack sizes: 4 pre-filled pens.

Marketing authorization holder

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

Marketing authorization dates and numbers

EU/1/21/1608/001
EU/1/21/1608/002
EU/1/21/1608/003
EU/1/21/1608/004
EU/1/21/1608/005

Drugs

Drug Countries
WEGOVY Canada, Estonia, Israel, Japan, Lithuania, Poland, Romania, United States

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