Gefitinib Pliva 250 mg filmom obložene tablete
| Name | Gefitinib Pliva 250 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-317459732 |
| Active Substance | gefitinib |
| Composition | jedna filmom obložena tableta sadrži 250 mg gefitiniba |
| Pharmaceutical Form | filmom obložena tableta |
| Manufacturer | Teva Pharma S.L.U., Zaragoza, Španjolska Merckle GmbH, Blaubeuren, Njemačka Pliva Hrvatska d.o.o., Zagreb, Hrvatska Balkanpharma - Dupnitsa AD, Dupnitsa, Bugarska |
| Marketing Authorisation Holder | Pliva Hrvatska d.o.o., Prilaz baruna Filipovića 25, Zagreb, Hrvatska |
| Marketing Authorisation Date | 17.08.2023 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/23-02/01 |
| Registration Number | 381-12-01/286-23-04 |
| 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 | L01EB01 |
| Marketing status | Marketed |
| Shortage status | No shortage |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |