Medicinal Products

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
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 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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