Tamaliz Duo 0,5 mg/0,4 mg tvrde kapsule
| Name | Tamaliz Duo 0,5 mg/0,4 mg tvrde kapsule |
|---|---|
| Marketing Authorisation Number | HR-H-520605602 |
| Active Substance | dutasterid tamsulozinklorid |
| Composition | svaka kapsula sadrži 0,5 mg dutasterida i 0,4 mg tamsulozinklorida (što odgovara 0,367 mg tamsulozina) |
| Pharmaceutical Form | kapsula, tvrda |
| 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 | 27.09.2024 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/24-02/55 |
| Registration Number | 381-12-01/286-24-03 |
| 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 | G04CA52 |
| Marketing status | Marketed |
| Shortage status | No shortage |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
Packaging
Direct Healthcare Professional Communication
| Name | Date | Download |
|---|---|---|
| Pismo zdravstvenim radnicima o mjerama za smanjenje rizika od suicidalnih misli povezanih s primjenom lijekova koji sadrže dutasterid i finasterid | 09.09.2025 | Zentiva, Viatris Hrvatska, Krka-farma, Genericon Pharma, Alpha-Medical, Belupo lijekovi i kozmetika, PharmaS, Galenika Adria, Pharmakos Consulting, Alkaloid, PLIVA Hrvatska, MIP Pharma Croatia, Organon Pharma |
