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PRODUCT DETAIL

Prolia 60 mg injekčný roztok v naplnenej injekčnej striekačke

Code 20095
MA number EU/1/10/618/001
Product Form: sol inj 1x1 ml/60 mg (striek.inj.napl.skl. v blistri)
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
Route of admin.: Subcutaneous use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 26.05.2010
SmPC + PL: European Medicines Agency's database
Dokument: DHPC Prolia informačná karta pacienta.pdf  
Dokument: DHPC Prolia 2 9 2014.pdf  
Dokument: DHPC Prolia 14 2 2013.pdf  
Safety feature Yes
Data update: 08.03.2024
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