REBLOZYL Powder for solution for injection Ref.[10651] Active ingredients: Luspatercept

Source: European Medicines Agency (EU)  Revision Year: 2020 

Product name and form

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.

Qualitative and quantitative composition

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)
Sodium citrate (E331)
Polysorbate 80
Sucrose
Hydrochloric acid (for pH adjustment)
Sodium hydroxide (for pH adjustment)

Pack sizes and marketing

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.

Marketing authorization dates and numbers

Celgene Europe B.V., Winthontlaan 6 N, 3526 KV Utrecht, Netherlands

EU/1/20/1452/001
EU/1/20/1452/002

Drugs

Drug Countries
REBLOZYL Austria, Canada, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, Turkey, United States

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