Medicinal Products

Kapetral 500 mg filmom obložene tablete

Name Kapetral 500 mg filmom obložene tablete
Marketing Authorisation Number HR-H-043893207
Active Substance kapecitabin
Composition jedna filmom obložena tableta sadrži 500 mg kapecitabina
Pharmaceutical Form filmom obložena tableta
Manufacturer Remedica Ltd., Limassol, Cipar
Marketing Authorisation Holder Alpha-Medical d.o.o., Dragutina Golika 36, Zagreb, Hrvatska
Marketing Authorisation Date 15.03.2019
MA Period of Validity unlimited
Classification Number UP/I-530-09/17-02/549
Registration Number 381-12-01/30-19-03
Prescription na recept
Type of prescription ograničeni recept
Distribution u ljekarni
Advertising to general public zabranjeno
ATC Code L01BC06
Medicinal product marketed in the Croatia Da
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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.
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