Azitromicin Belupo 500 mg filmom obložene tablete

Name	Azitromicin Belupo 500 mg filmom obložene tablete
Marketing Authorisation Number	HR-H-125410249
Active Substance	azitromicin dihidrat
Composition	jedna filmom obložena tableta sadrži 500 mg azitromicina u obliku azitromicin dihidrata
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	27.11.2019
MA Period of Validity	unlimited
Classification Number	UP/I-530-09/18-02/241
Registration Number	381-12-01/70-19-02
Prescription	Medicinal product subject to medical prescription
Type of prescription	neponovljivi recept
Distribution	Supply through pharmacies (community)
Advertising to general public	not allowed
ATC Code	J01FA10
Marketing status	stavljeno u promet
Shortage status	nema nestašice
SmPC	download
PL	download

Packaging

Packaging description	MA Number for Packaging	Marketing status	Shortage status
3 tablete u blisteru, u kutiji	HR-H-125410249-01	stavljeno u promet	nema nestašice

Direct Healthcare Professional Communication

Name	Date	Download
Pismo zdravstvenim radnicima o povećanoj stopi recidiva hematoloških maligniteta i smrtnosti kod bolesnika podvrgnutih transplantaciji hematopoetskih matičnih stanica (HSCT) liječenih azitromicinom	02.05.2018	Belupo lijekovi i kozmetika, Jadran – Galenski Laboratorij d.d., Krka-Farma d.o.o., PharmaS d.o.o., Pliva Hrvatska d.o.o. i Sandoz d.o.o.