| Name |
Alsemol 50 mg filmom obložene tablete |
| Marketing Authorisation Number |
HR-H-163501168 |
| Active Substance |
riluzol |
| Composition |
jedna filmom obložena tableta sadrži 50 mg riluzola |
| Pharmaceutical Form |
filmom obložena tableta |
| Manufacturer |
Glenmark Pharmaceuticals s.r.o., Vysoké Mýto, Češka |
| Marketing Authorisation Holder |
Makpharm d.o.o., Trnjanska cesta 37/1, Zagreb, Hrvatska |
| Marketing Authorisation Date |
31.07.2024 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/23-02/171 |
| Registration Number |
381-12-01/171-24-05 |
| 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 |
N07XX02 |
| Marketing status |
stavljeno u promet |
| Shortage status |
nema nestašice |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
