Medicinal Products

Bortezomib Pliva 3,5 mg prašak za otopinu za injekciju

Name Bortezomib Pliva 3,5 mg prašak za otopinu za injekciju
Marketing Authorisation Number HR-H-634138702
Active Substance bortezomib
Composition jedna bočica sadrži 3,5 mg bortezomiba (u obliku estera boronatne kiseline i manitola)
Pharmaceutical Form prašak za otopinu za injekciju
Packaging [MA Number for Packaging] 1 bočica s praškom, u kutiji  [HR-H-634138702-01]
Manufacturer S.C. Sindan-Pharma S.R.L., Bukurešt, Rumunjska
Marketing Authorisation Holder Pliva Hrvatska d.o.o., Prilaz baruna Filipovića 25, Zagreb, Hrvatska
Marketing Authorisation Date 19.07.2022
MA Period of Validity unlimited
Classification Number UP/I-530-09/19-02/206
Registration Number 381-12-01/154-22-02
Prescription na recept
Type of prescription ograničeni recept
Distribution u ljekarni
Advertising to general public zabranjeno
ATC Code L01XG01
Medicinal product marketed in the Croatia Nestašica
SmPC download
PL download
Public Assessment Report download
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