Emicizumab
Therapeutic Emicizumab antibody from the original Hemlibra® commercial drug.
Reference Standard as Aliquots
Product Batch | Therapeutic Expiry Date
| Brand & Origin
| Amount per Aliquot
| Select Quantity | Discount | Price per Aliquot
| |
|---|---|---|---|---|---|---|---|
2026.12 |
Hemlibra® DE |
2 mg |
Unit: aliquot(s) |
561,00 €/aliquot
|
Biosimilars as Aliquots
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Product Information
Here you will find the product information for the reference product.
Hemlibra® / Emicizumab Reference Product
| Drug name | Hemlibra® |
| INN | Emicizumab |
| API type | Emicizumab is a humanised monoclonal modified immunoglobulin G4 (IgG4) antibody produced using recombinant DNA technology in mammalian Chinese Hamster Ovary (CHO) cells |
| Pharmacotherapeutic group | Antihemorrhagics, other systemic hemostatics |
| ATC code | B02BX06 |
| Target of antibody | Coagulation factor IX Coagulation factor X |
| General function | Emicizumab is indicated for routine prophylaxis of bleeding episodes in patients with haemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors or for severe haemophilia A (congenital factor VIII deficiency, FVIII < 1%) without factor VIII inhibitors |
| Short description | |
| Pharmacodynamic properties (Mechanism of action; Source EMA document) | Emicizumab is a humanized monoclonal modified immunoglobulin G4 (IgG4) antibody with a bispecific antibody structure. Emicizumab bridges activated factor IX and factor X to restore the function of missing activated factor VIII that is needed for effective haemostasis. Emicizumab has no structural relationship or sequence homology to factor VIII and, as such, does not induce or enhance the development of direct inhibitors to factor VIII. |
| Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document) | Prophylactic therapy with Hemlibra shortens the aPTT and increases the reported factor VIII activity (using a chromogenic assay with human coagulation factors). These two pharmacodynamic markers do not reflect the true haemostatic effect of emicizumab in vivo (aPTT is overly shortened and reported factor VIII activity may be overestimated) but provide a relative indication of the procoagulant effect of emicizumab. |
| Original license holder | |
| Marketing authorisation numbers | EU/1/18/1271/001 |
| Marketing authorisation holder | Roche Registration GmbH Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany |
| Name of the manufacturer of the biological active substance | Chugai Pharma Manufacturing Co., Ltd. 5-1, Ukima 5-Chome Kita-Ku, Tokyo 115-8543 Japan |
| Name and address of the manufacturer(s) responsible for batch release | Roche Austria GmbH Engelhorngasse 3 1211 Wien Austria Roche Pharma AG Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany |
| Max shelf life | 30 months |
| Storage conditions | 2°C – 8°C (for the original pharmaceutical presentation for the use in humans) |
| List of excipients | L-Arginine L-Histidine L-Aspartic acid Poloxamer 188 Water for injections |
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