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	ponovljivi recept
Distribution	Supply through pharmacies (community)
Advertising to general public	not allowed
ATC Code	M04AA03
Marketing status	stavljeno u promet
Shortage status	nema nestašice
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	stavljeno u promet	nema nestašice

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.