Duitam 0,5 mg/0,4 mg tvrde kapsule
| Name | Duitam 0,5 mg/0,4 mg tvrde kapsule |
|---|---|
| Marketing Authorisation Number | HR-H-292296112 |
| 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 |
| Packaging [MA Number for Packaging] | 7 kapsula u bočici, u kutiji [HR-H-292296112-01] 30 kapsula u bočici, u kutiji [HR-H-292296112-02] 90 kapsula u bočici, u kutiji [HR-H-292296112-03] 98 kapsula u bočici, u kutiji [HR-H-292296112-04] 100 kapsula u bočici, u kutiji [HR-H-292296112-05] |
| Manufacturer | Laboratorios Leon Farma S.A., Villaquialambre, Leon, Španjolska
Genericon Pharma Gesellschaft m.b.H., Graz, Austrija |
| Marketing Authorisation Holder | Genericon Pharma Gesellschaft m.b.H., Hafnerstraße 211, Graz, Austrija |
| Marketing Authorisation Date | 28.11.2019 |
| MA Period of Validity | 28.11.2024 |
| Classification Number | UP/I-530-09/18-01/99 |
| Registration Number | 381-12-01/70-19-06 |
| 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 | Da |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
