| Name |
Xynito 240 mg tvrde želučanootporne kapsule |
| Marketing Authorisation Number |
HR-H-236825706 |
| Active Substance |
dimetilfumarat |
| Composition |
jedna tvrda kapsula sadrži 240 mg dimetilfumarata |
| Pharmaceutical Form |
Želučanootporna kapsula, tvrda |
| Manufacturer |
Glenmark Pharmaceuticals s.r.o., Vysoké Mýto, Češka |
| Marketing Authorisation Holder |
Alpha-Medical d.o.o., Dragutina Golika 36, Zagreb, Hrvatska |
| Marketing Authorisation Date |
04.09.2023 |
| MA Period of Validity |
04.09.2028 |
| Classification Number |
UP/I-530-09/22-01/57 |
| Registration Number |
381-12-01/154-23-07 |
| Prescription |
Medicinal product subject to medical prescription |
| Type of prescription |
ograničeni recept
|
| Distribution |
Supply through pharmacies (community) |
| Advertising to general public |
not allowed |
| ATC Code |
L04AX07 |
| Marketing status |
stavljeno u promet |
| Shortage status |
nema nestašice |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
