Awerkano 5 mg/160 mg/12,5 mg filmom obložene tablete
| Name | Awerkano 5 mg/160 mg/12,5 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-562050054 |
| Active Substance | amlodipinbesilat valsartan hidroklorotiazid |
| Composition | jedna filmom obložena tableta sadrži 5 mg amlodipina (u obliku amlodipinbesilata), 160 mg valsartana i 12,5 mg hidroklorotiazida |
| 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 | 24.10.2022 |
| MA Period of Validity | 24.10.2027 |
| Classification Number | UP/I-530-09/21-01/190 |
| Registration Number | 381-12-01/70-22-07 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | ponovljivi recept |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | C09DX01 |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
