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ANNEXI
SUMMARYOFPRODUCTCHARACTERISTICS
1
Thismedicinalproductissubjecttoadditionalmonitoring.Thiswillallowquickidentificationof
newsafetyinformation.Healthcareprofessionalsareaskedtoreportanysuspectedadversereactions.
Seesection4.8forhowtoreportadversereactions.
1.NAMEOFTHEMEDICINALPRODUCT
Winrevair45mgpowderandsolventforsolutionforinjection
Winrevair60mgpowderandsolventforsolutionforinjection
2.QUALITATIVEANDQUANTITATIVECOMPOSITION
Winrevair45mgpowderandsolventforsolutionforinjection
Eachvialcontains45mgofsotatercept.Afterreconstitution,eachmLofsolutioncontains50mg
sotatercept.
Winrevair60mgpowderandsolventforsolutionforinjection
Eachvialcontains60mgofsotatercept.Afterreconstitution,eachmLofsolutioncontains50mg
sotatercept.
Sotaterceptisarecombinanthomodimericfusionproteinconsistingoftheextracellulardomainof
humanactivinreceptortypeIIA(ActRIIA)linkedtotheFcdomainofhumanIgG1,producedin
ChineseHamsterOvary(CHO)cellsbyrecombinantDNAtechnology.
Forthefulllistofexcipients,seesection6.1.
3.PHARMACEUTICALFORM
Powderandsolventforsolutionforinjection(powderforinjection).
Powder:whitetooff-whitepowder.
Solvent:clearcolourlesswaterforinjections.
4.CLINICALPARTICULARS
4.1Therapeuticindications
Winrevair,incombinationwithotherpulmonaryarterialhypertension(PAH)therapies,isindicated
forthetreatmentofPAHinadultpatientswithWHOFunctionalClass(FC)IItoIII,toimprove
exercisecapacity(seesection5.1).
4.2Posologyandmethodofadministration
Winrevairtreatmentshouldonlybeinitiatedandmonitoredbyaphysicianexperiencedinthe
diagnosisandtreatmentofPAH.
Posology
Winrevairisadministeredonceevery3weeksasasinglesubcutaneousinjectiona
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