Fovelid 500 mg filmom obložene tablete

Name	Fovelid 500 mg filmom obložene tablete
Marketing Authorisation Number	HR-H-542485437
Active Substance	levofloksacin hemihidrat
Composition	jedna filmom obložena tableta sadrži 500 mg levofloksacina (u obliku levofloksacin hemihidrata)
Pharmaceutical Form	filmom obložena tableta
Manufacturer	Alkaloid - INT d.o.o., Ljubljana - Črnuče, Slovenija
Marketing Authorisation Holder	Alkaloid - INT d.o.o., Šlandrova ulica 4, Ljubljana - Črnuče, Slovenija
Marketing Authorisation Date	18.12.2024
MA Period of Validity	unlimited
Classification Number	UP/I-530-09/24-02/129
Registration Number	381-12-01/70-24-04
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	J01MA12
Marketing status	Marketed
Shortage status	No shortage
SmPC	download
PL	download
Public Assessment Report	download
Summary of risk management plan	download

Packaging

Packaging description	MA Number for Packaging	Marketing status	Shortage status
5 tableta u blisteru, u kutiji	HR-H-542485437-01	Never marketed	-
7 tableta u blisteru, u kutiji	HR-H-542485437-02	Never marketed	-
10 tableta u blisteru, u kutiji	HR-H-542485437-03	Marketed	No shortage

Direct Healthcare Professional Communication

Name	Date	Download
Pismo zdravstvenim radnicima s podsjetnikom na ograničenu primjenu fluorokinolonskih antibiotika zbog dugotrajnih, onesposobljavajućih i potencijalno ireverzibilnih nuspojava	13.06.2023	Sandoz d.o.o., Alkaloid d.o.o., Alkaloid-INT d.o.o., Belupo lijekovi i kozmetika d.d., Krka-Farma d.o.o., PharmaS d.o.o., Zentiva k.s., Pliva Hrvatska d.o.o., Jadran Galenski laboratorij d.d., Alpha-Medical d.o.o., Fresenius Kabi d.o.o.
Pismo zdravstvenim radnicima o riziku od regurgitacije/insuficijencije srčanih zalistaka uz primjenu fluorokinolona za sustavnu i inhalacijsku primjenu	29.10.2020	Alkaloid d.o.o, Sandoz d.o.o, Jadran Galenski laboratorij d.d., Belupo lijekovi i kozmetika d.d., Alpha-Medical d.o.o., KRKA-FARMA, d.o.o., PharmaS d.o.o., Alvogen d.o.o., Fresenius Kabi d.o.o., Pliva Hrvatska d.o.o.