Abuxar 80 mg filmom obložene tablete

Name	Abuxar 80 mg filmom obložene tablete
Marketing Authorisation Number	HR-H-347159881
Active Substance	febuksostat
Composition	jedna tableta sadrži 80 mg febuksostata
Pharmaceutical Form	filmom obložena tableta
Manufacturer	Belupo lijekovi i kozmetika d.d., Koprivnica, Hrvatska
Marketing Authorisation Holder	Belupo lijekovi i kozmetika d.d., Ulica Danica 5, Koprivnica, Hrvatska
Marketing Authorisation Date	09.12.2021
MA Period of Validity	unlimited
Classification Number	UP/I-530-09/21-02/158
Registration Number	381-12-01/154-21-03
Prescription	Medicinal product subject to medical prescription
Type of prescription	Medicinal product on medical prescription for renewable delivery
Distribution	Supply through pharmacies (community)
Advertising to general public	not allowed
ATC Code	M04AA03
Marketing status	Marketed
Shortage status	Actual
SmPC	download
PL	download
Public Assessment Report	download

Packaging

Packaging description	MA Number for Packaging	Marketing status	Shortage status
28 tableta u blisteru, u kutiji	HR-H-347159881-01	Marketed	Actual

Direct Healthcare Professional Communication

Name	Date	Download
Pismo zdravstvenim radnicima o povećanom riziku od kardiovaskularne smrti te povećanja smrtnosti zbog bilo kojeg uzroka u bolesnika liječenih febuksostatom u kliničkom ispitivanju CARES	28.06.2019	Menarini International Operations Luxembourg S.A., Teva B.V. i Belupo lijekovi i kozmetika d.d.