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PRODUCT DETAIL

Tepkinly 48 mg injekčný roztok

Code 4486E
MA number EU/1/23/1759/002
Product Form: sol inj 1x0,8 ml/48 mg (liek.inj.skl.)
MA Status: Ex - Conditional centralised marketing authorisation
Type of procedure: EU Orphan
MAH, country: AbbVie Deutschland GmbH & Co. KG, Germany
Shelf life: 24
Container: glass vial
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: 22.09.2023
Validity: 25.09.2025
SmPC + PL: European Medicines Agency's database
Dokument: Epkoritamab_Karta pacienta_20Dec2023_final.pdf  
Safety feature Yes
Data update: 05.08.2024
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