Dutamera 0,5 mg/0,4 mg tvrde kapsule
| Name | Dutamera 0,5 mg/0,4 mg tvrde kapsule |
|---|---|
| Marketing Authorisation Number | HR-H-894517516 |
| Active Substance | dutasterid tamsulozinklorid |
| Composition | svaka tvrda kapsula sadrži 0,5 mg dutasterida i 0,4 mg tamsulozinklorida (što odgovara 0,367 mg tamsulozina) |
| Pharmaceutical Form | Kapsula, tvrda |
| Manufacturer | Laboratorios Leon Farma S.A., Villaquialambre, Leon, Španjolska |
| Marketing Authorisation Holder | Galenika International Kft., Baross utca 165/3, Budaörs, Mađarska |
| Marketing Authorisation Date | 24.01.2025 |
| MA Period of Validity | 24.01.2030 |
| Classification Number | UP/I-530-09/23-01/107 |
| Registration Number | 381-12-01/70-25-10 |
| 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 | Never marketed |
| 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 |
