| Name |
Tosynal 5 mg filmom obložene tablete |
| Former Name |
Prasugrel Alkaloid-INT 5 mg filmom obložene tablete |
| Marketing Authorisation Number |
HR-H-220461124 |
| Active Substance |
prasugrel |
| Composition |
jedna tableta sadrži 5 mg prasugrela |
| Pharmaceutical Form |
filmom obložena tableta |
| Manufacturer |
Alkaloid - INT d.o.o., Ljubljana - Črnuče, Slovenija |
| Marketing Authorisation Holder |
Alkaloid - INT d.o.o., Šlandrova ulica 4, Ljubljana - Črnuče, Slovenija |
| Marketing Authorisation Date |
21.08.2024 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/24-02/34 |
| Registration Number |
381-12-01/70-24-04 |
| Prescription |
Medicinal product subject to medical prescription |
| Type of prescription |
Medicinal product on medical prescription for renewable delivery
|
| Distribution |
Supply through pharmacies (community) |
| Advertising to general public |
not allowed |
| ATC Code |
B01AC22 |
| Marketing status |
Never marketed |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
