Dimetilfumarat STADA 240 mg tvrde želučanootporne kapsule
| Name | Dimetilfumarat STADA 240 mg tvrde želučanootporne kapsule |
|---|---|
| Marketing Authorisation Number | HR-H-761739119 |
| Active Substance | dimetilfumarat |
| Composition | jedna tvrda želučanootporna kapsula sadrži 240 mg dimetilfumarata |
| Pharmaceutical Form | Želučanootporna kapsula, tvrda |
| Manufacturer | Pharmadox Healthcare Limited, Paola PLA, Malta
Clonmel Healthcare Ltd., Clonmel, Co. Tipperary, Irska Kevaro Group Ltd, Sofia, Bugarska STADA Arzneimittel GmbH, Beč, Austrija STADA Arzneimittel AG, Bad Vilbel, Njemačka AdAlvo Limited, San Gwann, Malta |
| Marketing Authorisation Holder | Stada d.o.o., Hercegovačka 14, Zagreb, Hrvatska |
| Marketing Authorisation Date | 24.01.2023 |
| MA Period of Validity | 24.01.2028 |
| Classification Number | UP/I-530-09/21-01/317 |
| Registration Number | 381-12-01/171-23-06 |
| 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 |
