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PRODUCT DETAIL

XGEVA 120 mg injekčný roztok

Code 09503
MA number EU/1/11/703/002
Product Form: sol inj 4x1,7 ml/120 mg (liek.inj.skl.)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
Therapeutic Class: 87 - VARIA I
ATC:
M MUSCULO-SKELETAL SYSTEM
M05 DRUGS FOR TREATMENT OF BONE DISEASES
M05B DRUGS AFFECTING BONE STRUCTURE AND MINERALIZATION
M05BX Other drugs affecting bone structure and mineralization
M05BX04 Denosumab
Shelf life: 36
Container: glass vial
Route of admin.: Subcutaneous use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 8(3) application - known active substance
MA issued: 13.07.2011
SmPC + PL: European Medicines Agency's database
Dokument: DHPC Xgeva ONJ update and Patient card 3 9 2015.pdf  
Dokument: DHPC Xgeva 2 9 2014.pdf  
Dokument: DHPC_XGEVA_hypokalciémia 31 8 2012.pdf  
Safety feature Yes
Data update: 17.09.2020
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