Medicinal Products

Fovelid 250 mg filmom obložene tablete

Name Fovelid 250 mg filmom obložene tablete
Marketing Authorisation Number HR-H-219972405
Active Substance levofloksacin hemihidrat
Composition jedna filmom obložena tableta sadrži 250 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 24.07.2020
MA Period of Validity 24.07.2025
Classification Number UP/I-530-09/19-01/172
Registration Number 381-12-01/38-20-04
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 J01MA12
Marketing status nije stavljeno u promet
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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.
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.
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