Xalvobin 500 mg filmom obložene tablete

Name	Xalvobin 500 mg filmom obložene tablete
Marketing Authorisation Number	HR-H-603766687
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	Zentiva k.s., U Kabelovny 130, Dolni Mecholupy, Prag 10, Češka
Marketing Authorisation Date	05.05.2021
MA Period of Validity	unlimited
Classification Number	UP/I-530-09/17-02/104
Registration Number	381-12-01/154-21-39
Prescription	Medicinal product subject to medical prescription
Type of prescription	ograničeni recept
Distribution	Supply through pharmacies (community)
Advertising to general public	not allowed
ATC Code	L01BC06
Marketing status	stavljeno u promet
Shortage status	nema nestašice
SmPC	download
PL	download

Packaging

Packaging description	MA Number for Packaging	Marketing status	Shortage status
120 tableta u blisteru, u kutiji	HR-H-603766687-01	stavljeno u promet	nema nestašice

Direct Healthcare Professional Communication

Name	Date	Download
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.