Dimtruzic 240 mg tvrde želučanootporne kapsule
| Name | Dimtruzic 240 mg tvrde želučanootporne kapsule |
|---|---|
| Marketing Authorisation Number | HR-H-631343747 |
| Active Substance | dimetilfumarat |
| Composition | jedna tvrda želučanootporna kapsula sadrži 240 mg dimetilfumarata |
| Pharmaceutical Form | Želučanootporna kapsula, tvrda |
| Manufacturer | Zakłady Farmaceutyczne Polpharma S.A., Nowa Dęba, Poljska
Lek Pharmaceuticals d.d., Ljubljana, Slovenija |
| Marketing Authorisation Holder | Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska |
| Marketing Authorisation Date | 30.09.2022 |
| MA Period of Validity | 30.09.2027 |
| Classification Number | UP/I-530-09/21-01/166 |
| Registration Number | 381-12-01/38-22-07 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | ograničeni recept |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | L04AX07 |
| Marketing status | privremeni prekid opskrbe |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
