Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Ultragenyx Germany GmbH, Rahel-Hirsch-Str. 10, 10557 Berlin, Germany
Evkeeza 150 mg/ml concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion (sterile concentrate). Clear to slightly opalescent, colourless to pale yellow sterile solution with a pH of 6.0 and an osmolality of approximately 500 mmol/kg. |
Each ml of concentrate for solution for infusion contains 150 mg of evinacumab.
One vial of 2.3 ml of concentrate contains 345 mg of evinacumab.
One vial of 8 ml of concentrate contains 1,200 mg of evinacumab.
Evinacumab is produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Evinacumab |
Evinacumab is a recombinant human monoclonal antibody, which specifically binds to and inhibits ANGPTL3. ANGPTL3 is a member of the angiopoietin-like protein family that is expressed primarily in the liver and plays a role in the regulation of lipid metabolism by inhibiting lipoprotein lipase (LPL) and endothelial lipase (EL). Evinacumab blockade of ANGPTL3 lowers TG and HDL-C by releasing LPL and EL activities from ANGPTL3 inhibition, respectively. |
| List of Excipients |
|---|
|
Proline |
2.3 ml of concentrate in a 3 ml clear Type 1 glass vial with a grey chlorobutyl stopper with coating and a seal cap with a flip-off button containing 345 mg of evinacumab. Pack size of 1 vial.
8 ml of concentrate in a 20 ml clear Type 1 glass vial, with a grey chlorobutyl stopper with coating and a seal cap with a flip-off button containing 1 200 mg of evinacumab. Pack size of 1 vial.
Not all pack sizes may be marketed.
Ultragenyx Germany GmbH, Rahel-Hirsch-Str. 10, 10557 Berlin, Germany
EU/1/21/1551/001
EU/1/21/1551/002
Date of first authorisation: 17 June 2021
| Drug | Countries | |
|---|---|---|
| EVKEEZA | Estonia, France, Croatia, Ireland, Italy, Lithuania, Poland, United Kingdom, United States |
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