Kllotas 0,5 mg/0,4 mg tvrde kapsule
| Name | Kllotas 0,5 mg/0,4 mg tvrde kapsule |
|---|---|
| Marketing Authorisation Number | HR-H-034911914 |
| Active Substance | dutasterid tamsulozinklorid |
| Composition | jedna tvrda kapsula sadrži 0,5 mg dutasterida i 0,4 mg tamsulozinklorida (ekvivalentno 0,367 mg tamsulozina). |
| Pharmaceutical Form | kapsula, tvrda |
| Manufacturer | Belupo lijekovi i kozmetika d.d., Koprivnica, Hrvatska |
| Marketing Authorisation Holder | Belupo lijekovi i kozmetika d.d., Ulica Danica 5, Koprivnica, Hrvatska |
| Marketing Authorisation Date | 20.03.2024 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/23-02/200 |
| Registration Number | 381-12-01/171-24-03 |
| 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 |
