| Name |
Bosutinib Teva 500 mg filmom obložene tablete |
| Marketing Authorisation Number |
HR-H-001312523 |
| Active Substance |
bosutinib dihidrat |
| Composition |
jedna filmom obložena tableta sadrži 500 mg bosutiniba (u obliku bosutinib dihidrata) |
| Pharmaceutical Form |
Filmom obložena tableta |
| Manufacturer |
Pharmadox Healthcare Limited, Paola, Malta |
| Marketing Authorisation Holder |
Teva GmbH, Graf-Arco-Strasse 3, Ulm, Njemačka |
| Marketing Authorisation Date |
23.08.2024 |
| MA Period of Validity |
23.08.2029 |
| Classification Number |
UP/I-530-09/22-01/259 |
| Registration Number |
381-12-01/171-24-08 |
| Prescription |
Medicinal product subject to medical prescription |
| Type of prescription |
Medicinal product subject to restricted medical prescription
|
| Distribution |
Supply through pharmacies (community) |
| Advertising to general public |
not allowed |
| ATC Code |
L01EA04 |
| Marketing status |
Marketed |
| Shortage status |
No shortage |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
