Sumamed 1500, 200 mg/5 ml prašak za oralnu suspenziju

Name	Sumamed 1500, 200 mg/5 ml prašak za oralnu suspenziju
Former Name	Sumamed 1200 XL, 200 mg/5 ml prašak za oralnu suspenziju
Marketing Authorisation Number	HR-H-096496463
Active Substance	azitromicin dihidrat
Composition	5 ml suspenzije sadrži 200 mg azitromicina u obliku azitromicin dihidrata
Pharmaceutical Form	prašak 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	20.06.2016
MA Period of Validity	unlimited
Classification Number	UP/I-530-09/14-02/374
Registration Number	381-12-01/30-16-11
Prescription	Medicinal product subject to medical prescription
Type of prescription	neponovljivi recept
Distribution	Supply through pharmacies (community)
Advertising to general public	not allowed
ATC Code	J01FA10
Marketing status	stavljeno u promet
Shortage status	nema nestašice
SmPC	download
PL	download

Packaging

Packaging description	MA Number for Packaging	Marketing status	Shortage status
1 bočica s praškom za pripremu 37,5 ml suspenzije i štrcaljka za doziranje, u kutiji	HR-H-096496463-01	stavljeno u promet	nema nestašice

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.