Bosentan Zentiva 125 mg filmom obložene tablete
| Name | Bosentan Zentiva 125 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-932085265 |
| Active Substance | bosentan hidrat |
| Composition | jedna filmom obložena tableta sadrži 125 mg bosentana (129,08 mg u obliku bosentan hidrata) |
| Pharmaceutical Form | Filmom obložena tableta |
| Manufacturer | Zentiva S.A., Bukurešt, Rumunjska
Winthrop Arzneimittel GmbH, Frankfurt am Main, Njemačka Zentiva k.s., Prag 10, Češka 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-530-09/23-01/148 |
| Registration Number | 381-12-01/70-24-05 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | ograničeni recept |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | C02KX01 |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Educational materials for patients / caregivers |
Bosentan Zentiva Kartica za bolesnika |
