Sumamed 500 mg prašak za koncentrat za otopinu za infuziju

Name	Sumamed 500 mg prašak za koncentrat za otopinu za infuziju
Former Name	Sumamed 500 mg injekcije
Marketing Authorisation Number	HR-H-261024118
Active Substance	azitromicin dihidrat
Composition	svaka bočica sadrži 500 mg azitromicina u obliku azitromicin citrata
Pharmaceutical Form	prašak za koncentrat za otopinu za infuziju
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	20.06.2016
MA Period of Validity	unlimited
Classification Number	UP/I-530-09/14-02/294
Registration Number	381-12-01/30-16-12
Prescription	Medicinal product subject to medical prescription
Type of prescription	Medicinal product subject to restricted medical prescription
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

Packaging

Packaging description	MA Number for Packaging	Marketing status	Shortage status
5 bočica s praškom, u kutiji	HR-H-261024118-01	Marketed	No shortage

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.