Jaxteran 240 mg tvrde želučanootporne kapsule
Name | Jaxteran 240 mg tvrde želučanootporne kapsule |
---|---|
Marketing Authorisation Number | HR-H-590208962 |
Active Substance | dimetilfumarat |
Composition | jedna želučanootporna kapsula sadrži 240 mg dimetilfumarata |
Pharmaceutical Form | Želučanootporna kapsula, tvrda |
Manufacturer | Pharmadox Healthcare Limited, Paola, Malta AdAlvo Limited, San Gwann, Malta Kevaro Group Ltd, Sofia, Bugarska |
Marketing Authorisation Holder | Zentiva k.s., U Kabelovny 130, Dolni Mecholupy, Prag 10, Češka |
Marketing Authorisation Date | 06.02.2023 |
MA Period of Validity | 06.02.2028 |
Classification Number | UP/I-530-09/22-01/100 |
Registration Number | 381-12-01/70-23-08 |
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 |