Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Novo Nordisk A/S, Novo Alle 1, DK-2880 Bagsvaerd, Denmark
Alhemo 15 mg/1.5 mL solution for injection in pre-filled pen.
Alhemo 60 mg/1.5 mL solution for injection in pre-filled pen.
Alhemo 150 mg/1.5 mL solution for injection in pre-filled pen.
Alhemo 300 mg/3 mL solution for injection in pre-filled pen.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). Clear to slightly opalescent, colourless to slightly yellow liquid and practically free from visible particles, that may contain translucent to white particles of protein. Isotonic solution with pH of approximately 6. |
Alhemo 15 mg/1.5 mL solution for injection in pre-filled pen:
One mL solution contains 10 mg concizumab*. Each pre-filled pen contains 15 mg of concizumab in 1.5 mL solution (10 mg/mL).
Alhemo 60 mg/1.5 mL solution for injection in pre-filled pen:
One mL solution contains 40 mg concizumab*. Each pre-filled pen contains 60 mg of concizumab in 1.5 mL solution (40 mg/mL).
Alhemo 150 mg/1.5 mL solution for injection in pre-filled pen:
One mL solution contains 100 mg concizumab*. Each pre-filled pen contains 150 mg of concizumab in 1.5 mL solution (100 mg/mL).
Alhemo 300 mg/3 mL solution for injection in pre-filled pen:
One mL solution contains 100 mg concizumab*. Each pre-filled pen contains 300 mg of concizumab in 3 mL solution (100 mg/mL).
* Concizumab is a humanised IgG4 monoclonal antibody produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Concizumab |
Concizumab is an anti-tissue factor pathway inhibitor (anti-TFPI) antibody. TFPI is an inhibitor of factor Xa (FXa). Concizumab binding to TFPI prevents TFPI inhibition of FXa. The increased FXa activity prolongs the initiation phase of coagulation and allows sufficient thrombin generation for effective haemostasis. Concizumab acts independently from FVIII and FIX. |
| List of Excipients |
|---|
|
L-Arginine hydrochloride |
Alhemo is provided in a portable multi-dose disposable pre-filled pen, which consists of a 1.5 mL or 3 mL glass cartridge sealed in a pen-injector, made of plastic components and metal springs. The cartridge is closed at the bottom with a rubber disc, and at the top with a laminate rubber disc sealed with an aluminium cap. The rubber discs are not made with natural rubber latex.
The pre-filled pen is packed in a carton. Alhemo is available in the following pack sizes, and the dose button and the cartridge holder on the pen-injector is colour–coded according to strength:
Not all pack sizes may be marketed.
Injection needles are not included. Alhemo is designed to be used with NovoFine Plus or NovoFine needles with a gauge of 32 and a length of 4 mm. If needles longer than 4 mm are used, injection techniques that minimise the risk of intramuscular injection should be used, e.g. injecting into a loosely held skinfold.
Novo Nordisk A/S, Novo Alle 1, DK-2880 Bagsvaerd, Denmark
EU/1/24/1881/001
EU/1/24/1881/002
EU/1/24/1881/003
EU/1/24/1881/004
EU/1/24/1881/005
EU/1/24/1881/006
EU/1/24/1881/007
| Drug | Countries | |
|---|---|---|
| ALHEMO | Lithuania, United States |
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