Aksitinib Teva 1 mg filmom obložene tablete
| Name | Aksitinib Teva 1 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-000312769 |
| Active Substance | aksitinib |
| Composition | jedna filmom obložena tableta sadrži 1 mg aksitiniba |
| Pharmaceutical Form | Filmom obložena tableta |
| Manufacturer | Synthon Hispania S.L., Barcelona, Španjolska
Synthon BV, Nijmegen, Nizozemska Balkanpharma - Dupnitsa AD, Dupnitsa, Bugarska |
| Marketing Authorisation Holder | Teva GmbH, Graf-Arco-Strasse 3, Ulm, Njemačka |
| Marketing Authorisation Date | 18.06.2024 |
| MA Period of Validity | 18.06.2029 |
| Classification Number | UP/I-530-09/23-01/132 |
| Registration Number | 381-12-01/70-24-08 |
| 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 | L01EK01 |
| Marketing status | Marketed |
| Shortage status | No shortage |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
