Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: UCB Pharma S.A., Allée de la Recherche, 60, B-1070 Bruxelles, Belgium
EVENITY 105 mg solution for injection in pre-filled pen.
EVENITY 105 mg solution for injection in pre-filled syringe.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). Clear to opalescent, colorless to light yellow solution. |
EVENITY 105 mg solution for injection in pre-filled pen: Each pre-filled pen contains 105 mg of romosozumab in 1.17 ml of solution (90 mg/ml).
EVENITY 105 mg solution for injection in pre-filled syringe: Each pre-filled syringe contains 105 mg of romosozumab in 1.17 ml of solution (90 mg/ml).
Romosozumab is a humanized IgG2 monoclonal antibody produced using recombinant DNA technology in Chinese hamster ovary (CHO) cells.
Excipients with known effect: Each pre-filled pen and each pre-filled syringe contains 0.07 mg polysorbate 20.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Romosozumab |
Romosozumab is a humanized monoclonal antibody (IgG2) that binds and inhibits sclerostin, thereby increasing bone formation due to the activation of bone lining cells, increasing bone matrix production by osteoblasts, and recruitment of osteoprogenitor cells. Additionally, romosozumab results in changes to expression of osteoclast mediators, thereby decreasing bone resorption. |
| List of Excipients |
|---|
|
Calcium acetate |
EVENITY 105 mg solution for injection in pre-filled pen:
A single use, disposable, handheld, mechanical injection device pre-assembled with pre-filled syringe containing 1.17 ml solution. The syringe inside the pen is made from cyclo olefin polymer plastic with a stopper (chlorobutyl) and insert molded stainless steel needle with elastomeric needle shield (synthetic rubber).
Pack size of 2 pre-filled pens.
Multipack containing 6 (3 packs of 2) pre-filled pens.
EVENITY 105 mg solution for injection in pre-filled syringe:
A single use, disposable, pre-filled syringe containing 1.17 ml solution. The syringe is made from cyclo olefin polymer plastic with a stopper (chlorobutyl) and insert molded stainless steel needle and elastomeric needle shield (synthetic rubber).
Pack size of 2 pre-filled syringes.
Multipack containing 6 (3 packs of 2) pre-filled syringes.
Not all pack sizes may be marketed.
UCB Pharma S.A., Allée de la Recherche, 60, B-1070 Bruxelles, Belgium
EU/1/19/1411/001
EU/1/19/1411/002
EU/1/19/1411/003
EU/1/19/1411/004
Date of first authorisation: 09 December 2019
| Drug | Countries | |
|---|---|---|
| EVENITY | Austria, Australia, Brazil, Canada, Estonia, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, Turkey, United Kingdom, United States |
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