Kapecitabin Sandoz 500 mg filmom obložene tablete
| Name | Kapecitabin Sandoz 500 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-795038747 |
| Active Substance | kapecitabin |
| Composition | jedna filmom obložena tableta sadrži 500 mg kapecitabina |
| Pharmaceutical Form | filmom obložena tableta |
| Manufacturer | Salutas Pharma GmbH, Barleben, Njemačka Lek Pharmaceuticals d.d., Ljubljana, Slovenija |
| Marketing Authorisation Holder | Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska |
| Marketing Authorisation Date | 03.04.2019 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/17-02/522 |
| Registration Number | 381-12-01/70-19-08 |
| 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 | L01BC06 |
| Marketing status | stavljeno u promet |
| Shortage status | nema nestašice |
| SmPC | download |
| PL | download |
Packaging
Direct Healthcare Professional Communication
| Name | Date | Download |
|---|---|---|
| Pismo zdravstvenim radnicima o potrebi testiranja bolesnika prije započinjanja liječenja lijekovima s djelatnim tvarima fluorouracil, kapecitabin ili tegafur radi utvrđivanja mogućeg nedostatka DPD enzima koji bolesnike izlaže povećanom riziku od teške toksičnosti | 04.06.2020 | Roche Registration GmbH, Jadran Galenski laboratorij d.d. (JGL), Alpha-Medical d.o.o., Sandoz d.o.o., Alvogen Pharma Trading Europe EOOD, Pliva Hrvatska d.o.o., Krka-farma d.o.o., Teva B.V., Accord Healthcare S.L.U. |
