Dimtelzo 120 mg tvrde želučanootporne kapsule
| Name | Dimtelzo 120 mg tvrde želučanootporne kapsule |
|---|---|
| Marketing Authorisation Number | HR-H-359538546 |
| Active Substance | dimetilfumarat |
| Composition | jedna tvrda želučanootporna kapsula sadrži 120 mg dimetilfumarata |
| Pharmaceutical Form | Želučanootporna kapsula, tvrda |
| Manufacturer | Pharmadox Healthcare Limited, Paola, Malta
Lek Pharmaceuticals d.d., Ljubljana, Slovenija AdAlvo Limited, San Gwann, Malta |
| Marketing Authorisation Holder | Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska |
| Marketing Authorisation Date | 15.09.2023 |
| MA Period of Validity | 15.09.2028 |
| Classification Number | UP/I-530-09/22-01/48 |
| Registration Number | 381-12-01/154-23-09 |
| 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 |
