Source: European Medicines Agency (EU) Revision Year: 2020
Reblozyl 25 mg powder for solution for injection.
Reblozyl 75 mg powder for solution for injection.
| Pharmaceutical Form |
|---|
|
Powder for solution for injection (powder for injection). White to off-white lyophilised powder. |
Reblozyl 25 mg powder for solution for injection: Each vial contains 25 mg of luspatercept. After reconstitution, each mL of solution contains 50 mg luspatercept.
Reblozyl 75 mg powder for solution for injection: Each vial contains 75 mg of luspatercept. After reconstitution, each mL of solution contains 50 mg luspatercept.
Luspatercept 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 | |
|---|---|---|
| Luspatercept |
Luspatercept, an erythroid maturation agent, is a recombinant fusion protein that binds selected transforming growth factor-β (TGF-β) superfamily ligands. By binding to specific endogenous ligands (e.g. GDF-11, activin B) luspatercept inhibits Smad2/3 signalling, resulting in erythroid maturation through differentiation of late-stage erythroid precursors (normoblasts) in the bone marrow. |
| List of Excipients |
|---|
|
Citric acid monohydrate (E330) |
Reblozyl 25 mg powder for solution for injection: 3 mL Type I glass vial with a hydrophobic inner coating closed with a bromobutyl rubber stopper and aluminium seal with yellow polypropylene flip-off cap.
Reblozyl 75 mg powder for solution for injection: 3 mL Type I glass vial with a hydrophobic inner coating closed with a bromobutyl rubber stopper and aluminium seal with orange polypropylene flip-off cap.
Pack size: 1 vial.
Celgene Europe B.V., Winthontlaan 6 N, 3526 KV Utrecht, Netherlands
EU/1/20/1452/001
EU/1/20/1452/002
| Drug | Countries | |
|---|---|---|
| REBLOZYL | Austria, Canada, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, Turkey, United States |
© 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.
