Jaxteran 120 mg tvrde želučanootporne kapsule
| Name | Jaxteran 120 mg tvrde želučanootporne kapsule |
|---|---|
| Marketing Authorisation Number | HR-H-602822615 |
| Active Substance | dimetilfumarat |
| Composition | jedna želučanootporna kapsula sadrži 120 mg dimetilfumarata |
| Pharmaceutical Form | Želučanootporna kapsula, tvrda |
| Manufacturer | AdAlvo Limited, San Gwann, Malta Pharmadox Healthcare Limited, Paola, Malta Kevaro Group Ltd, Sofia, Bugarska |
| Marketing Authorisation Holder | Zentiva k.s., U Kabelovny 130, Dolni Mecholupy, Prag 10, Češka |
| Marketing Authorisation Date | 06.02.2023 |
| MA Period of Validity | 06.02.2028 |
| Classification Number | UP/I-530-09/22-01/99 |
| Registration Number | 381-12-01/70-23-10 |
| Prescription | na recept |
| Type of prescription | ograničeni recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | L04AX07 |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
