Bortezomib PharmaS 3,5 mg prašak za otopinu za injekciju
Name | Bortezomib PharmaS 3,5 mg prašak za otopinu za injekciju |
---|---|
Marketing Authorisation Number | HR-H-002821692 |
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-002821692-01] |
Manufacturer | Synthon Hispania S.L., Barcelona, Španjolska
Synthon s.r.o., Blansko, Češka |
Marketing Authorisation Holder | PharmaS d.o.o., Radnička cesta 47, Zagreb, Hrvatska |
Marketing Authorisation Date | 15.05.2020 |
MA Period of Validity | unlimited |
Classification Number | UP/I-530-09/19-02/177 |
Registration Number | 381-12-01/70-20-05 |
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 | Da |
SmPC | download |
PL | download |
Public Assessment Report | download |