Bosentan Zentiva 62,5 mg filmom obložene tablete
Name | Bosentan Zentiva 62,5 mg filmom obložene tablete |
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Marketing Authorisation Number | HR-H-593966867 |
Active Substance | bosentan hidrat |
Composition | jedna filmom obložena tableta sadrži 62,5 mg bosentana (64,54 mg u obliku bosentan hidrata) |
Pharmaceutical Form | Filmom obložena tableta |
Manufacturer | Winthrop Arzneimittel GmbH, Frankfurt am Main, Njemačka Zentiva k.s., Prag 10, Češka Zentiva S.A., Bukurešt, Rumunjska ITC Production s.r.l., Pomezia , Italija |
Marketing Authorisation Holder | Zentiva k.s., U Kabelovny 130, Dolni Mecholupy, Prag 10, Češka |
Marketing Authorisation Date | 23.01.2024 |
MA Period of Validity | 23.01.2029 |
Classification Number | UP/I-530-09/23-01/147 |
Registration Number | 381-12-01/70-24-07 |
Prescription | na recept |
Type of prescription | ograničeni recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | C02KX01 |
SmPC | download |
PL | download |
Public Assessment Report | download |