Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: CSL Behring GmbH, Emil-von-Behring-Strasse 76, D-35041 Marburg, Germany
ANDEMBRY 200 mg solution for injection in pre-filled syringe.
ANDEMBRY 200 mg solution for injection in pre-filled pen.
| Pharmaceutical Form |
|---|
|
Solution for injection. The solution is a slightly opalescent to clear, brownish-yellow to yellow liquid. The solution has a pH of approximately 6.1 and an osmolality of approximately 470 mOsm/kg. |
ANDEMBRY 200 mg solution for injection in pre-filled syringe: Each pre-filled syringe contains 200 mg of garadacimab* in 1.2 mL solution.
ANDEMBRY 200 mg solution for injection in pre-filled pen: Each pre-filled pen contains 200 mg of garadacimab* in 1.2 mL solution.
* Garadacimab is a fully human IgG4 monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
Excipients with known effect: Each pre-filled syringe/pen contains 19.3 mg of proline and 0.24 mg of polysorbate 80.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Garadacimab |
|
| List of Excipients |
|---|
|
Histidine |
ANDEMBRY 200 mg solution for injection in pre-filled syringe:
1.2 mL of solution in a pre-filled glass syringe (type I glass) with a bromobutyl stopper, 27G x ½ 5B special thin-walled (STW) staked needle, and is assembled with an extended finger flange and needle safety device.
ANDEMBRY is available as unit packs containing 1 assembled pre-filled syringe and in multipacks containing 3 (3 packs of 1) assembled pre-filled syringes.
ANDEMBRY 200 mg solution for injection in pre-filled pen:
1.2 mL of solution in a pre-filled glass syringe (type I glass) with a bromobutyl stopper, 27G x ½ 5B special thin-walled (STW) staked needle. Each pre-filled syringe is assembled with a pen.
ANDEMBRY is available as unit packs containing 1 assembled pre-filled pen and in multipacks containing 3 (3 packs of 1) assembled pre-filled pens.
Not all pack sizes may be marketed.
CSL Behring GmbH, Emil-von-Behring-Strasse 76, D-35041 Marburg, Germany
EU/1/24/1885/001
EU/1/24/1885/002
EU/1/24/1885/003
EU/1/24/1885/004
| Drug | Countries | |
|---|---|---|
| ANDEMBRY | Lithuania, United Kingdom |
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