Alsemol 50 mg filmom obložene tablete
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 | 30.07.2019 |
MA Period of Validity | 30.07.2024 |
Classification Number | UP/I-530-09/17-01/299 |
Registration Number | 381-12-01/38-19-10 |
Prescription | na recept |
Type of prescription | ograničeni recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | N07XX02 |
Medicinal product marketed in the Croatia | Da |
SmPC | download |
PL | download |
Public Assessment Report | download |
Summary of risk management plan | download |