Dutamyz 0,5 mg/0,4 mg tvrde kapsule
| Name | Dutamyz 0,5 mg/0,4 mg tvrde kapsule |
|---|---|
| Marketing Authorisation Number | HR-H-689760661 |
| Active Substance | dutasterid tamsulozinklorid |
| Composition | jedna tvrda kapsula sadrži 0,5 mg dutasterida i 0,4 mg tamsulozinklorida (što odgovara 0,367 mg tamsulozina). |
| Pharmaceutical Form | kapsula, tvrda |
| Packaging [MA Number for Packaging] | 7 kapsula u bočici, u kutiji [HR-H-689760661-01] 30 kapsula u bočici, u kutiji [HR-H-689760661-02] 90 kapsula u bočici, u kutiji [HR-H-689760661-03] |
| Manufacturer | Laboratorios Leon Farma S.A., Villaquialambre, Leon, Španjolska
Krka d.d., Novo mesto, Novo Mesto, Slovenija |
| Marketing Authorisation Holder | Krka - farma d.o.o., Radnička cesta 48, Zagreb, Hrvatska |
| Marketing Authorisation Date | 28.11.2019 |
| MA Period of Validity | 28.11.2024 |
| Classification Number | UP/I-530-09/18-01/250 |
| Registration Number | 381-12-01/70-19-05 |
| Prescription | na recept |
| Type of prescription | ponovljivi recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | G04CA52 |
| Medicinal product marketed in the Croatia | Ne |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
