Linezolid Sandoz 2 mg/ml otopina za infuziju
Name | Linezolid Sandoz 2 mg/ml otopina za infuziju |
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Marketing Authorisation Number | HR-H-249166135 |
Active Substance | linezolid |
Composition | 1 ml otopine za infuziju sadrži 2 mg linezolida; jedna infuzijska vrećica od 300 ml sadrži 600 mg linezolida |
Pharmaceutical Form | otopina za infuziju |
Manufacturer | Synthon BV, Nijmegen, Nizozemska Synthon Hispania S.L., Barcelona, Španjolska Lek Pharmaceuticals d.d., Ljubljana, Slovenija Sandoz GmbH, Kundl, Austrija Salutas Pharma GmbH, Barleben, Njemačka |
Marketing Authorisation Holder | Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska |
Marketing Authorisation Date | 30.11.2018 |
MA Period of Validity | unlimited |
Classification Number | UP/I-530-09/18-02/113 |
Registration Number | 381-12-01/70-18-03 |
Prescription | na recept |
Type of prescription | ograničeni recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | J01XX08 |
Medicinal product marketed in the Croatia | Trajni prekid opskrbe |
SmPC | download |
PL | download |
Public Assessment Report | download |