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ANNEXI
SUMMARYOFPRODUCTCHARACTERISTICS
1
1.NAMEOFTHEMEDICINALPRODUCT
Zeposia0.23mghardcapsules
Zeposia0.46mghardcapsules
Zeposia0.92mghardcapsules
2.QUALITATIVEANDQUANTITATIVECOMPOSITION
Zeposia0.23mghardcapsules
Eachhardcapsulecontainsozanimodhydrochlorideequivalentto0.23mgozanimod.
Zeposia0.46mghardcapsules
Eachhardcapsulecontainsozanimodhydrochlorideequivalentto0.46mgozanimod.
Zeposia0.92mghardcapsules
Eachhardcapsulecontainsozanimodhydrochlorideequivalentto0.92mgozanimod.
Forthefulllistofexcipients,seesection6.1.
3.PHARMACEUTICALFORM
Hardcapsule
Zeposia0.23mghardcapsules
Lightgreyopaquehardcapsule,14.3mm,imprintedinblackinkwith“OZA”onthecapand
“0.23mg”onthebody.
Zeposia0.46mghardcapsules
Lightgreyopaquebodyandorangeopaquecaphardcapsule,14.3mm,imprintedinblackinkwith
“OZA”onthecapand“0.46mg”onthebody.
Zeposia0.92mghardcapsules
Orangeopaquehardcapsule,14.3mm,imprintedinblackinkwith“OZA”onthecapand“0.92mg”
onthebody.
4.CLINICALPARTICULARS
4.1Therapeuticindications
Multiplesclerosis
Zeposiaisindicatedforthetreatmentofadultpatientswithrelapsingremittingmultiplesclerosis
(RRMS)withactivediseaseasdefinedbyclinicalorimagingfeatures.
2
Ulcerativecolitis
Zeposiaisindicatedforthetreatmentofadultpatientswithmoderatelytoseverelyactiveulcerative
colitis(UC)whohavehadaninadequateresponse,lostresponse,orwereintoleranttoeither
conventionaltherapyorabiologicagent.
4.2Posologyandmethodofadministration
Treatmentshouldbeinitiatedunderthesupervisionofaphysicianexperiencedinthemanagementof
multiplesclerosis(MS)orulcerativecolitis(UC).
Posology
Theinitialdosee
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