Levofloksacin Sandoz 5 mg/ml otopina za infuziju
| Name | Levofloksacin Sandoz 5 mg/ml otopina za infuziju |
|---|---|
| Marketing Authorisation Number | HR-H-290574554 |
| Active Substance | levofloksacin hemihidrat |
| Composition | 1 ml otopine za infuziju sadrži 5 mg levofloksacina u obliku levofloksacin hemihidrata |
| Pharmaceutical Form | otopina za infuziju |
| Manufacturer | Lek Pharmaceuticals d.d., Ljubljana, Slovenija Pharmaceutical Works Polpharma S.A., Starogard Gdanski , Poljska |
| Marketing Authorisation Holder | Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska |
| Marketing Authorisation Date | 04.08.2021 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/19-02/246 |
| Registration Number | 381-12-01/38-21-04 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | ograničeni recept |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | J01MA12 |
| Marketing status | stavljeno u promet |
| Shortage status | nema nestašice |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
Packaging
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. |
