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PRODUCT DETAIL

EVENITY 105 mg injekčný roztok naplnený v injekčnom pere

Code 4539D
MA number EU/1/19/1411/001
Product Form: sol inj 2x1,17 ml/105 mg (striek.inj.napl. v pere)
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
M05BX06 Romosozumab
Shelf life: 36
Container: pre-filled syringe
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: 09.12.2019
Validity: 09.12.2024
SmPC + PL: European Medicines Agency's database
Dokument: EVENITY_Karta pacienta.pdf  
Dokument: EVENITY_Prirucka pre lekara.pdf  
Safety feature Yes
Data update: 15.05.2020
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