Sumamed 500 mg tablete za oralnu suspenziju

Name	Sumamed 500 mg tablete za oralnu suspenziju
Marketing Authorisation Number	HR-H-120748759
Active Substance	azitromicin dihidrat
Composition	svaka tableta za oralnu suspenziju sadrži 500 mg azitromicina u obliku azitromicin dihidrata
Pharmaceutical Form	tableta za oralnu suspenziju
Manufacturer	Pliva Hrvatska d.o.o., Zagreb, Hrvatska
Marketing Authorisation Holder	Pliva Hrvatska d.o.o., Prilaz baruna Filipovića 25, Zagreb, Hrvatska
Marketing Authorisation Date	30.01.2023
MA Period of Validity	unlimited
Classification Number	UP/I-530-09/22-02/72
Registration Number	381-12-01/70-23-03
Prescription	Medicinal product subject to medical prescription
Type of prescription	Medicinal product on medical prescription for non-renewable delivery
Distribution	Supply through pharmacies (community)
Advertising to general public	not allowed
ATC Code	J01FA10
Marketing status	Marketed
Shortage status	No shortage
SmPC	download
PL	download
Public Assessment Report	download

Packaging

Packaging description	MA Number for Packaging	Marketing status	Shortage status
1 tableta u blisteru, u kutiji	HR-H-120748759-01	Never marketed	-
2 tablete u blisteru, u kutiji	HR-H-120748759-02	Never marketed	-
3 tablete u blisteru, u kutiji	HR-H-120748759-03	Marketed	No shortage
6 tableta u blisteru, u kutiji	HR-H-120748759-04	Never marketed	-
12 tableta u blisteru, u kutiji	HR-H-120748759-05	Never marketed	-
24 tablete u blisteru, u kutiji	HR-H-120748759-06	Never marketed	-

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.