Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany
Hemlibra 30 mg/mL solution for injection.
Hemlibra 150 mg/mL solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection. Colourless to slightly yellow solution. |
Hemlibra 30 mg/mL solution for injection:
Each mL of solution contains 30 mg of emicizumab*.
Each vial of 1 mL contains 30 mg of emicizumab at a concentration of 30 mg/mL.
Hemlibra 150 mg/mL solution for injection:
Each mL of solution contains 150 mg of emicizumab*.
Each vial of 0.4 mL contains 60 mg of emicizumab at a concentration of 150 mg/mL.
Each vial of 0.7 mL contains 105 mg of emicizumab at a concentration of 150 mg/mL.
Each vial of 1 mL contains 150 mg of emicizumab at a concentration of 150 mg/mL.
* Emicizumab is a humanised monoclonal modified immunoglobulin G4 (IgG4) antibody produced using recombinant DNA technology in mammalian Chinese Hamster Ovary (CHO) cells
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Emicizumab |
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. |
| List of Excipients |
|---|
|
L-Arginine |
Hemlibra 30 mg/mL solution for injection:
3 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film and crimped with an aluminium cap fitted with a plastic flip-off disk. Each vial contains 30 mg emicizumab in 1 mL of solution for injection. Each carton contains one vial.
Hemlibra 150 mg/mL solution for injection:
3 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film and crimped with an aluminium cap fitted with a plastic flip-off disk. Each vial contains 60 mg emicizumab in 0.4 mL of solution for injection. Each carton contains one vial.
3 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film and crimped with an aluminium cap fitted with a plastic flip-off disk. Each vial contains 105 mg emicizumab in 0.7 mL of solution for injection. Each carton contains one vial.
3 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film and crimped with an aluminium cap fitted with a plastic flip-off disk. Each vial contains 150 mg emicizumab in 1 mL of solution for injection. Each carton contains one vial.
Not all pack sizes may be marketed.
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany
EU/1/18/1271/001 (30 mg/1 ml)
EU/1/18/1271/002 (60 mg/0.4 ml)
EU/1/18/1271/003 (105 mg/0.7 ml)
EU/1/18/1271/004 (150 mg/1 ml)
Date of first authorisation: 23 February 2018
| Drug | Countries | |
|---|---|---|
| HEMLIBRA | Austria, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
