Azitromicin Sandoz forte 200 mg/5 ml prašak za oralnu suspenziju

Name	Azitromicin Sandoz forte 200 mg/5 ml prašak za oralnu suspenziju
Marketing Authorisation Number	HR-H-117564216
Active Substance	azitromicin dihidrat
Composition	5 ml pripremljene suspenzije sadrži 200 mg azitromicina u obliku azitromicin dihidrata 1 ml pripremljene suspenzije sadrži 40 mg azitromicina u obliku azitromicin dihidrata
Pharmaceutical Form	prašak za oralnu suspenziju
Manufacturer	S.C. Sandoz S.R.L., Targu Mures, Rumunjska
Marketing Authorisation Holder	Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska
Marketing Authorisation Date	17.01.2020
MA Period of Validity	unlimited
Classification Number	UP/I-530-09/17-02/761
Registration Number	381-12-01/70-20-05
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

Packaging

Packaging description	MA Number for Packaging	Marketing status	Shortage status
1 bočica s praškom, odmjerna štrcaljka, u kutiji	HR-H-117564216-01	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.