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 | na recept |
Type of prescription | ograničeni recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | L04AX07 |
Medicinal product marketed in the Croatia | Da |
SmPC | download |
PL | download |
Public Assessment Report | download |
Summary of risk management plan | download |