Doksazosin/finasterid MIP 4 mg/5 mg filmom obložene tablete
| Name | Doksazosin/finasterid MIP 4 mg/5 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-505954353 |
| Active Substance | finasterid doksazosinmesilat |
| Composition | svaka filmom obložena tableta sadrži 4 mg doksazosina (u obliku mesilata) i 5 mg finasterida |
| Pharmaceutical Form | Filmom obložena tableta |
| Manufacturer | MIP Pharma GmbH, St. Ingbert, Njemačka |
| Marketing Authorisation Holder | MIP Pharma Croatia d.o.o., Mihanovićeva 14, Zagreb, Hrvatska |
| Marketing Authorisation Date | 17.01.2025 |
| MA Period of Validity | 17.01.2030 |
| Classification Number | UP/I-530-09/22-01/281 |
| Registration Number | 381-12-01/70-25-09 |
| 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 | G04CA55 |
| Marketing status | nije stavljeno u promet |
| 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 |
