Medicinal Products

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
Packaging [MA Number for Packaging] 12 tableta u blisteru, u kutiji  [HR-H-987938644-01]
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
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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.
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