Dutrys 0,5 mg meke kapsule
| Name | Dutrys 0,5 mg meke kapsule |
|---|---|
| Marketing Authorisation Number | HR-H-020313732 |
| Active Substance | dutasterid |
| Composition | svaka meka kapsula sadrži 0,5 mg dutasterida |
| Pharmaceutical Form | kapsula, meka |
| Manufacturer | Krka d.d. Novo mesto, Novo Mesto, Slovenija Laboratorios Leon Farma S.A., Villaquialambre, Leon, Španjolska |
| Marketing Authorisation Holder | Krka - farma d.o.o., Radnička cesta 48, Zagreb, Hrvatska |
| Marketing Authorisation Date | 01.09.2021 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/21-02/21 |
| Registration Number | 381-12-01/38-21-05 |
| 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 | G04CB02 |
| Marketing status | stavljeno u promet |
| Shortage status | u tijeku |
| SmPC | download |
| PL | download |
| Public Assessment Report | 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 |
