Daleron COLD filmom obložene tablete
| Name | Daleron COLD filmom obložene tablete |
|---|---|
| Former Name | Daleron COLD3 filmom obložene tablete |
| Marketing Authorisation Number | HR-H-987938644 |
| Active Substance | paracetamol pseudoefedrinklorid dekstrometorfanbromid |
| Composition | jedna filmom obložena tableta sadrži 325 mg paracetamola, 30 mg pseudoefedrinklorida što odgovara 24,6 mg pseudoefedrina i 15 mg dekstrometorfanbromida što odgovara 11 mg dekstrometorfana |
| Pharmaceutical Form | filmom obložena tableta |
| Manufacturer | Krka d.d., Novo mesto, Novo Mesto, Slovenija |
| Marketing Authorisation Holder | Krka - farma d.o.o., Radnička cesta 48, Zagreb, Hrvatska |
| Marketing Authorisation Date | 16.05.2023 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/18-02/192 |
| Registration Number | 381-12-01/154-23-11 |
| Prescription | bez recepta |
| Distribution | u ljekarni |
| Advertising to general public | dopušteno |
| ATC Code | N02BE71 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
Packaging
Direct Healthcare Professional Communication
| Name | Date | Download |
|---|---|---|
| Pismo zdravstvenim radnicima o riziku od sindroma posteriorne reverzibilne encefalopatije i sindroma reverzibilne cerebralne vazokonstrikcije uz primjenu lijekova koji sadrže pseudoefedrin | 09.02.2024 | Alkaloid d.o.o., Bayer d.o.o., Pliva Hrvatska d.o.o., Reckitt Benckiser d.o.o., Krka - farma d.o.o., Bosnalijek d.o.o., Jadran Galenski laboratorij d.d. |
