Makromicin 500 mg filmom obložene tablete

Name	Makromicin 500 mg filmom obložene tablete
Marketing Authorisation Number	HR-H-692751502
Active Substance	azitromicin dihidrat
Composition	1 tableta sadrži 500 mg azitromicina u obliku azitromicin dihidrata
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	29.03.2017
MA Period of Validity	unlimited
Classification Number	UP/I-530-09/16-02/158
Registration Number	381-12-01/30-17-04
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-692751502-01	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.