Bortezomib EVER Pharma 2,5 mg/ml otopina za injekciju
Name | Bortezomib EVER Pharma 2,5 mg/ml otopina za injekciju |
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Marketing Authorisation Number | HR-H-234275465 |
Active Substance | bortezomib |
Composition | 1 ml otopine za injekciju sadrži 2,5 mg bortezomiba (u obliku estera boronatne kiseline i manitola) jedna bočica s 1 ml otopine za injekciju sadrži 2,5 mg bortezomiba (u obliku estera boronatne kiseline i manitola) jedna bočica s 1,4 ml otopine za injekciju sadrži 3,5 mg bortezomiba (u obliku estera boronatne kiseline i manitola) |
Pharmaceutical Form | otopina za injekciju |
Manufacturer | Ever Pharma Jena GmbH, Jena, Njemačka Ever Pharma Jena GmbH, Jena, Njemačka |
Marketing Authorisation Holder | EVER Valinject GmbH, Oberburgau 3, Unterach am Attersee, Austrija |
Marketing Authorisation Date | 13.10.2022 |
MA Period of Validity | 13.10.2027 |
Classification Number | UP/I-530-09/22-01/97 |
Registration Number | 381-12-01/70-22-07 |
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 |