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	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-795038747-01	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.