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
Packaging [MA Number for Packaging]	120 tableta u blisteru, u kutiji [HR-H-685310481-01]
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	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
SmPC	download
PL	download
Public Assessment Report	download

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.