Ortalox 20 mg želučanootporne kapsule
| Name | Ortalox 20 mg želučanootporne kapsule |
|---|---|
| Marketing Authorisation Number | HR-H-419263235 |
| Active Substance | omeprazol |
| Composition | jedna kapsula sadrži 20 mg omeprazola |
| Pharmaceutical Form | želučanootporna kapsula, tvrda |
| Packaging [MA Number for Packaging] | 1 bočica s 14 kapsula, u kutiji [HR-H-419263235-01] 1 bočica s 28 kapsula, u kutiji [HR-H-419263235-02] |
| Manufacturer | Jadran Galenski laboratorij d.d., Rijeka, Hrvatska Teva Pharma S.L.U., Zaragoza, Španjolska |
| Marketing Authorisation Holder | Jadran Galenski laboratorij d.d., Svilno 20, Rijeka, Hrvatska |
| Marketing Authorisation Date | 13.06.2017 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/16-02/278 |
| Registration Number | 381-12-01/70-17-04 |
| Prescription | na recept |
| Type of prescription | ponovljivi recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | A02BC01 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
