WINREVAIR Powder and solvent for solution for injection Ref.[114917] Active ingredients: Sotatercept

Source: European Medicines Agency (EU)  Revision Year: 2024  Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

Product name and form

Winrevair 45 mg powder and solvent for solution for injection.

Winrevair 60 mg powder and solvent for solution for injection.

Pharmaceutical Form

Powder and solvent for solution for injection (powder for injection).

Powder: white to off-white powder.

Solvent: clear colourless water for injections.

Qualitative and quantitative composition

Winrevair 45 mg powder and solvent for solution for injection: Each vial contains 45 mg of sotatercept. After reconstitution, each mL of solution contains 5 0 mg sotatercept.

Winrevair 60 mg powder and solvent for solution for injection: Each vial contains 60 mg of sotatercept. After reconstitution, each mL of solution contains 50 mg sotatercept.

Sotatercept is a recombinant homodimeric fusion protein consis ting of the extracellular domain of human activin receptor type IIA (ActRIIA) linked to the Fc domain of human IgG1, produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.

For the full list of excipients, see section 6.1.

Active Ingredient

Sotatercept is an activin signalling inhibitor with high selectivity for Activin-A, a dimeric glycoprotein which belongs to the transforming growth factor-β (TGF-β) superfamily of ligands. Activin-A binds to the activin receptor type IIA (ActRIIA) regulating key signalling for inflammation, cell proliferation, apoptosis, and tissue homeostasis.
List of Excipients

Powder:

Citric acid monohydrate (E330)
Sodium citrate (E331)
Polysorbate 80 (E433)
Sucrose

Solvent:

Water for injections

Pack sizes and marketing

Winrevair 45 mg powder and solvent for solution for injection:

2 mL capacity, type I glass vial sealed with a bromobutyl rubber stopper with polymer coating and aluminium seal with lime polypropylene flip-off cap containing 45 mg of sotatercept.

Prefilled syringe (type I glass cartridge closed with a bromobutyl rubber stopper) with 1 mL of solvent.

Winrevair 60 mg powder and solvent for solution for injection:

2 mL capacity, type I glass vial sealed with a bromobutyl rubber stopper with polymer coating and aluminium seal with burgundy polypropylene flip-off cap containing 60 mg of sotatercept.

Prefilled syringe (type I glass cartridge closed with a bromobutyl rubber stopper) with 1.3 mL of solvent.

Winrevair powder and solvent for solution for injection is available as the following pack sizes:

  • Kits containing 1 vial with 45 mg powder, 1 prefilled syringe with 1.0 mL solvent, 1 dosing syringe with 0.1 mL graduations, 1 vial adaptor (13 mm), 1 needle for injection and 4 alcohol wipes.
  • Kits containing 2 vials with 45 mg powder, 2 prefilled syringe s with 1.0 mL solvent, 1 dosing syringe with 0.1 mL graduations, 2 vial adaptors (13 mm), 1 needle for injection and 8 alcohol wipes.
  • Kits containing 1 vial with 60 mg powder, 1 prefilled syringe with 1.3 mL solvent, 1 dosing syringe with 0.1 mL graduations, 1 vial adaptor (13 mm), 1 needle for injection and 4 alcohol wipes.
  • Kits containing 2 vials with 60 mg powder, 2 prefilled syringe s with 1.3 mL solvent, 1 dosing syringe with 0.1 mL graduations, 2 vial adaptors (13 mm), 1 needle for injection and 8 alcohol wipes.

Not all pack sizes may be marketed.

Marketing authorization holder

Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

Marketing authorization dates and numbers

EU/1/24/1850/001
EU/1/24/1850/002
EU/1/24/1850/003
EU/1/24/1850/004

Drugs

Drug Countries
WINREVAIR United States
 
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