Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark
Ozempic 0.25 mg solution for injection in pre-filled pen.
Ozempic 0.5 mg solution for injection in pre-filled pen.
Ozempic 1 mg solution for injection in pre-filled pen.
Ozempic 2 mg solution for injection in pre-filled pen.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). Clear and colourless or almost colourless, isotonic solution; pH=7.4. |
Ozempic 0.25 mg solution for injection:
One ml of solution contains 1.34 mg of semaglutide*. One pre-filled pen contains 2 mg semaglutide* in 1.5 ml solution. Each dose contains 0.25 mg of semaglutide in 0.19 ml solution.
Ozempic 0.5 mg solution for injection:
1.5 mL: One ml of solution contains 1.34 mg of semaglutide*. One pre-filled pen contains 2 mg semaglutide* in 1.5 ml solution. Each dose contains 0.5 mg of semaglutide in 0.37 ml solution.
3 mL: One ml of solution contains 0.68 mg of semaglutide*. One pre-filled pen contains 2 mg semaglutide* in 3 mL solution. Each dose contains 0.5 mg of semaglutide in 0.74 mL solution.
Ozempic 1 mg solution for injection:
One ml of solution contains 1.34 mg of semaglutide*. One pre-filled pen contains 4 mg semaglutide* in 3 ml solution. Each dose contains 1 mg of semaglutide in 0.74 ml solution.
Ozempic 2 mg solution for injection:
One ml of solution contains 2.68 mg of semaglutide*. One pre-filled pen contains 8 mg semaglutide* in 3 ml solution. Each dose contains 2 mg of semaglutide in 0.74 ml solution.
* 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 |
1.5 ml or 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.
Ozempic 0.25 mg solution for injection:
Each pre-filled pen contains 1.5 ml of solution, delivering 4 doses of 0.25 mg.
1 pre-filled pen and 4 disposable NovoFine Plus needles
Ozempic 0.5 mg solution for injection:
1.5 mL: Each pre-filled pen contains 1.5 ml of solution, delivering 4 doses of 0.5 mg.
1 pre-filled pen and 4 disposable NovoFine Plus needles
3 pre-filled pens and 12 disposable NovoFine Plus needles
3 mL: Each pre-filled pen contains 3 mL of solution, delivering 4 doses of 0.5 mg.
1 pre-filled pen and 4 disposable NovoFine Plus needles
3 pre-filled pens and 12 disposable NovoFine Plus needles
Ozempic 1 mg solution for injection:
Each pre-filled pen contains 3 ml of solution, delivering 4 doses of 1 mg.
1 pre-filled pen and 4 disposable NovoFine Plus needles
3 pre-filled pens and 12 disposable NovoFine Plus needles
Ozempic 2 mg solution for injection:
Each pre-filled pen contains 3 ml of solution, delivering 4 doses of 2 mg.
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/1/17/1251/002
EU/1/17/1251/003
EU/1/17/1251/004
EU/1/17/1251/005
EU/1/17/1251/006
EU/1/17/1251/010
EU/1/17/1251/011
EU/1/17/1251/012
EU/1/17/1251/013
Date of first authorisation: 08 February 2018
Date of latest renewal: 21 September 2022
| Drug | Countries | |
|---|---|---|
| OZEMPIC | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, Poland, Romania, Turkey, United Kingdom, United States |
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