Source: European Medicines Agency (EU) Revision Year: 2019 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.
| 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: 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.
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 3.0 ml solution. Each dose contains 1 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.
Pack sizes:
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: 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.
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.
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
Date of first authorisation: 08 February 2018
| 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 |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
