Kapecitabin JGL 500 mg filmom obložene tablete

Name	Kapecitabin JGL 500 mg filmom obložene tablete
Marketing Authorisation Number	HR-H-685310481
Active Substance	kapecitabin
Composition	jedna filmom obložena tableta sadrži 500 mg kapecitabina
Pharmaceutical Form	filmom obložena tableta
Manufacturer	Jadran Galenski laboratorij d.d., Rijeka, Hrvatska
Marketing Authorisation Holder	Jadran Galenski laboratorij d.d., Svilno 20, Rijeka, Hrvatska
Marketing Authorisation Date	15.11.2021
MA Period of Validity	unlimited
Classification Number	UP/I-530-09/20-02/137
Registration Number	381-12-01/70-21-07
Prescription	Medicinal product subject to medical prescription
Type of prescription	Medicinal product subject to restricted medical prescription
Distribution	Supply through pharmacies (community)
Advertising to general public	not allowed
ATC Code	L01BC06
Marketing status	Marketed
Shortage status	No shortage
SmPC	download
PL	download
Public Assessment Report	download

Packaging

Packaging description	MA Number for Packaging	Marketing status	Shortage status
120 tableta u blisteru, u kutiji	HR-H-685310481-01	Marketed	No shortage

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.