Ciprofloksacin Sandoz 200 mg/100 ml otopina za infuziju
Name | Ciprofloksacin Sandoz 200 mg/100 ml otopina za infuziju |
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Marketing Authorisation Number | HR-H-364139536 |
Active Substance | ciprofloksacinklorid |
Composition | svaka bočica od 100 ml otopine za infuziju sadrži 200 mg ciprofloksacina u obliku ciprofloksacinklorid hidrata |
Pharmaceutical Form | otopina za infuziju |
Manufacturer | Salutas Pharma GmbH, Barleben, Njemačka
Sandoz GmbH, Kundl, Austrija |
Marketing Authorisation Holder | Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska |
Marketing Authorisation Date | 13.12.2019 |
MA Period of Validity | unlimited |
Classification Number | UP/I-530-09/17-02/532 |
Registration Number | 381-12-01/70-19-03 |
Prescription | na recept |
Type of prescription | ograničeni recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | J01MA02 |
Medicinal product marketed in the Croatia | Nestašica |
SmPC | download |
PL | download |
Summary of risk management plan | download |
Packaging
Direct Healthcare Professional Communication
Name | Date | Download |
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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. |