Dimetilfumarat STADA 120 mg tvrde želučanootporne kapsule
Name | Dimetilfumarat STADA 120 mg tvrde želučanootporne kapsule |
---|---|
Marketing Authorisation Number | HR-H-934523966 |
Active Substance | dimetilfumarat |
Composition | jedna tvrda želučanootporna kapsula sadrži 120 mg dimetilfumarata |
Pharmaceutical Form | Želučanootporna kapsula, tvrda |
Manufacturer | STADA Arzneimittel GmbH, Beč, Austrija
AdAlvo Limited, San Gwann, Malta STADA Arzneimittel AG, Bad Vilbel, Njemačka Clonmel Healthcare Ltd., Clonmel, Co. Tipperary, Irska Pharmadox Healthcare Limited, Paola PLA, Malta Kevaro Group Ltd, Sofia, Bugarska |
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-530-09/21-01/316 |
Registration Number | 381-12-01/171-23-08 |
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 |