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PRODUCT DETAIL

Rolcya 60 mg injekčný roztok v naplnenej injekčnej striekačke

Code 0859F
MA number EU/1/25/1958/001
Product Form: sol inj 1x60 mg/1 ml (striek.inj.napl.skl.)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
MAH, country: Sandoz GmbH, Austria
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 10(4) similar biological application
MA issued: 17.07.2025
Validity: 17.07.2030
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 13.08.2025
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