Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark
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.
Wegovy 0.25 mg FlexTouch solution for injection in pre-filled pen.
Wegovy 0.5 mg FlexTouch solution for injection in pre-filled pen.
Wegovy 1 mg FlexTouch solution for injection in pre-filled pen.
Wegovy 1.7 mg FlexTouch solution for injection in pre-filled pen.
Wegovy 2.4 mg FlexTouch solution for injection in pre-filled pen.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). Clear and colourless isotonic solution; pH=7.4. |
Wegovy 0.25 mg solution for injection: Each single-dose 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-dose 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-dose 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-dose 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-dose pre-filled pen contains 2.4 mg semaglutide* in 0.75 mL solution. One mL of solution contains 3.2 mg of semaglutide*.
Wegovy 0.25 mg FlexTouch solution for injection pre-filled pen: Each pre-filled pen contains 1 mg semaglutide* in 1.5 mL solution. One mL of solution contains 0.68 mg semaglutide*. One pre-filled pen contains 4 doses of 0.25 mg.
Wegovy 0.5 mg FlexTouch solution for injection pre-filled pen:
1.5 mL: Each pre-filled pen contains 2 mg semaglutide* in 1.5 mL solution. One mL of solution contains 1.34 mg semaglutide*. One pre-filled pen contains 4 doses of 0.5 mg.
3 mL: Each pre-filled pen contains 2 mg semaglutide* in 3 mL solution. One mL of solution contains 0.68 mg semaglutide*. One pre-filled pen contains 4 doses of 0.5 mg.
Wegovy 1 mg FlexTouch solution for injection pre-filled pen: Each pre-filled pen contains 4 mg semaglutide* in 3 mL solution. One mL of solution contains 1.34 mg semaglutide*. One pre-filled pen contains 4 doses of 1 mg.
Wegovy 1.7 mg FlexTouch solution for injection pre-filled pen: Each pre-filled pen contains 6.8 mg semaglutide* in 3 mL solution. One mL of solution contains 2.27 mg semaglutide*. One pre-filled pen contains 4 doses of 1.7 mg.
Wegovy 2.4 mg FlexTouch solution for injection pre-filled pen: Each pre-filled pen contains 9.6 mg semaglutide* in 3 mL solution. One mL of solution contains 3.2 mg semaglutide*. One pre-filled pen contains 4 doses of 2.4 mg.
* 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 |
|---|
|
Pre-filled pen, single-dose: Disodium phosphate, dihydrate Pre-filled pen, FlexTouch: Disodium phosphate, dihydrate |
Pre-filled pen, single-dose:
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).
Pre-filled pen, FlexTouch (0.25, 0.5 mg) 1.5 mL pre-filled pen:
1.5 mL glass cartridge (type I glass) closed at the one end with a rubber plunger (chlorobutyl) and at the other end with an aluminium cap with a laminated rubber sheet (bromobutyl/polyisoprene) inserted. The cartridge is assembled into a disposable pre-filled pen made of polypropylene, polyoxymethylene, polycarbonate and acrylonitrile butadiene styrene.
Pre-filled pen, FlexTouch (0.5 1, 1.7 and 2.4 mg) 3 mL pre-filled pen:
3 mL glass cartridge (type I glass) closed at the one end with a rubber plunger (chlorobutyl) and at the other end with an aluminium cap with a laminated rubber sheet (bromobutyl/polyisoprene) inserted.
The cartridge is assembled into a disposable pre-filled pen made of polypropylene, polyoxymethylene, polycarbonate and acrylonitrile butadiene styrene.
Pack sizes:
Pre-filled pen, single-dose (0.25, 0.5, 1, 1.7 and 2.4 mg)
Pack size of 4 pre-filled pens.
Pre-filled pen, FlexTouch (0.25, 0.5, 1 and 1.7 mg)
Pack size of 1 pre-filled pen and 4 disposable NovoFine Plus needles.
Pre-filled pen, FlexTouch (2.4 mg)
Pack sizes:
1 pre-filled pen and 4 disposable NovoFine Plus needles.
3 pre-filled pens and 12 disposable NovoFine Plus needles.
Not all pack sizes may be marketed.
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark
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
EU/1/21/1608/006
EU/1/21/1608/007
EU/1/21/1608/008
EU/1/21/1608/009
EU/1/21/1608/010
EU/1/21/1608/011
EU/1/21/1608/012
Date of first authorisation: 06 January 2022
| Drug | Countries | |
|---|---|---|
| WEGOVY | Austria, Canada, Estonia, Spain, France, Croatia, Israel, Italy, Japan, Lithuania, Poland, Romania, United States |
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