Medicinal Products

Bortezomib Alpha-Medical 3,5 mg prašak za otopinu za injekciju

Name Bortezomib Alpha-Medical 3,5 mg prašak za otopinu za injekciju
Marketing Authorisation Number HR-H-781716538
Active Substance bortezomibum
Pharmaceutical Form prašak za otopinu za injekciju
Strength 3,5 mg
Packaging [MA Number for Packaging] 1 bočica s praškom, u kutiji  [HR-H-781716538-01]
Manufacturer Pharmidea LLC, Olaine, Latvija
Marketing Authorisation Holder Alpha-Medical d.o.o., Dragutina Golika 36, Zagreb
Marketing Authorisation Date 24.06.2015
MA Period of Validity 24.06.2020
Classification Number UP/I-530-09/14-01/148
Registration Number 381-12-01/70-15-07
Composition svaka bočica sadrži 3,5 mg bortezomiba (u obliku estera boronatne kiseline i manitola)
Prescription na recept
Type of prescription ograničeni recept
Distribution u ljekarni
Advertising to general public zabranjeno
ATC Code L01XX32
Medicinal product marketed in the Croatia Da
SmPC download
PL download
Public Assessment Report download
Educational materials
for healthcare professionals
Brošura s uputstvima o pripremi, doziranju i primjeni, verzija 3
Grafikon sheme liječenja, verzija 2
Pomična mjerka s uputama za doziranje, verzija 2
Poster s uputstvima za pripremu lijeka, verzija 3
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