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PRODUCT DETAIL

Saphnelo 120 mg injekčný roztok v naplnenom pere

Code 2383F
MA number EU/1/21/1623/003
Product Form: sol inj 1x0,8 ml/120 mg (pero napl.)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
MAH, country: AstraZeneca AB, Sweden
Therapeutic Class: 59 - IMMUNOPRAEPARATA
ATC:
L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L04 Immunosuppressants
L04A Immunosuppressants
L04AG ?
L04AG11 Anifrolumab
Shelf life: 48
Route of admin.: Subcutaneous use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 14.02.2022
Validity: 14.02.2027
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 19.01.2026
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