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 | Medicinal product not subject to medical prescription |
Distribution | Supply through pharmacies (community) |
Advertising to general public | allowed |
ATC Code | N02BE71 |
Marketing status | stavljeno u promet |
Shortage status | nema nestašice |
SmPC | download |
PL | download |
Packaging
Direct Healthcare Professional Communication
Name | Date | Download |
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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. |