Medicinal Products

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 na recept
Type of prescription neponovljivi recept
Distribution u ljekarni
Advertising to general public zabranjeno
ATC Code J01FA10
Medicinal product marketed in the Croatia Da
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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.
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