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 |