Erlotinib Sandoz 100 mg filmom obložene tablete
| Name | Erlotinib Sandoz 100 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-127343397 |
| Active Substance | erlotinibum |
| Pharmaceutical Form | filmom obložena tableta |
| Strength | 100 mg |
| Packaging [MA Number for Packaging] | 30 tableta u blisteru, u kutiji [HR-H-127343397-01] |
| Manufacturer | Remedica Ltd., Limassol, Cipar Lek Pharmaceuticals d.d., Ljubljana, Slovenija |
| Marketing Authorisation Holder | Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska |
| Marketing Authorisation Date | 27.06.2017 |
| MA Period of Validity | 27.06.2022 |
| Classification Number | UP/I-530-09/16-01/117 |
| Registration Number | 381-12-01/30-17-04 |
| Composition | svaka filmom obložena tableta sadrži 100 mg erlotiniba (u obliku erlotinibklorida) |
| Prescription | na recept |
| Type of prescription | ograničeni recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | L01XE03 |
| Medicinal product marketed in the Croatia | Ne |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Educational materials for healthcare professionals |
Brošura za zdravstvene radnike, verzija 2 |
