Medicinal Products

Azitromicin Belupo 250 mg filmom obložene tablete

Name Azitromicin Belupo 250 mg filmom obložene tablete
Marketing Authorisation Number HR-H-162267682
Active Substance azitromicin dihidrat
Composition jedna filmom obložena tableta sadrži 250 mg azitromicina u obliku azitromicin dihidrata
Pharmaceutical Form filmom obložena tableta
Manufacturer Belupo lijekovi i kozmetika d.d., Koprivnica, Hrvatska
Marketing Authorisation Holder Belupo lijekovi i kozmetika d.d., Ulica Danica 5, Koprivnica, Hrvatska
Marketing Authorisation Date 27.11.2019
MA Period of Validity unlimited
Classification Number UP/I-530-09/18-02/240
Registration Number 381-12-01/70-19-03
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

Packaging

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.
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