Medicinal Products

Vortemyel 3,5 mg prašak za otopinu za injekciju

Name Vortemyel 3,5 mg prašak za otopinu za injekciju
Marketing Authorisation Number HR-H-398570556
Active Substance bortezomib
Composition svaka 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-398570556-01]
Manufacturer Synthon Hispania S.L., Barcelona, Španjolska
Synthon s.r.o., Blansko, Češka
Marketing Authorisation Holder Zentiva k.s., U Kabelovny 130, Dolni Mecholupy, Prag 10, Češka
Marketing Authorisation Date 09.03.2021
MA Period of Validity unlimited
MA Revocation Date 28.07.2022*
Classification Number UP/I-530-09/19-02/181
Registration Number 381-12-01/154-21-18
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 Trajni prekid opskrbe
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

*Note

Marketing authorisation has been revoked by request of the marketing authorisation holder. In accordance with Article 113 of Medicinal Products Act (Official Gazette No. 76/13), only a medicinal product in respect of which a marketing authorisation has been granted by the Agency for Medicinal Products and Medical Devices or the European Commision, and a medicinal product in respect of which an authorisation for parallel import or parallel distribution has been granted may be placed on the market of the Republic of Croatia. By way of derogation from this provision, a batch of medicinal product may be on the market for no longer than 18 months following the expiry of revocation of the marketing authorisation, unless its shelf life expires first.

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