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PRODUCT DETAIL

Zeposia 0,23 mg/0,46 mg tvrdé kapsuly

Code 4910D
MA number EU/1/20/1442/001
Product Form: cps dur 7 (4x0,23 mg + 3x0,46 mg) (blis. PVC/PCTFE/Al)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
MAH, country: Bristol-Myers Squibb Pharma EEIG , Ireland
Therapeutic Class: 59 - IMMUNOPRAEPARATA
ATC:
L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L04 Immunosuppressants
L04A Immunosuppressants
L04AA Selective immunosuppressants
L04AA38 Ozanimod
Shelf life: 36
Container: blister PVC/PCTFE/Al
Route of admin.: Oral use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 20.05.2020
Validity: 20.05.2025
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 19.10.2020
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