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PRODUCT DETAIL

CRYSVITA 20 mg injekčný roztok

Code 7443C
MA number EU/1/17/1262/002
Product Form: sol inj 1x1 ml/20 mg (liek.inj.skl.)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU Orphan
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
M05BX05 Burosumab
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 - new active substance
MA issued: 19.02.2018
Validity: 21.09.2027
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 24.10.2022
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