Linezolid Sandoz 2 mg/ml otopina za infuziju
| Name | Linezolid Sandoz 2 mg/ml otopina za infuziju |
|---|---|
| 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 |
