Dulsevia 30 mg tvrde želučanootporne kapsule
| Name | Dulsevia 30 mg tvrde želučanootporne kapsule |
|---|---|
| Marketing Authorisation Number | HR-H-728493948 |
| Active Substance | duloksetinklorid |
| Composition | svaka tvrda želučanootporna kapsula sadrži 30 mg duloksetina (u obliku duloksetinklorida) |
| Pharmaceutical Form | želučanootporna kapsula, tvrda |
| Packaging [MA Number for Packaging] | 7 kapsula u blisteru, u kutiji [HR-H-728493948-01] 10 kapsula u blisteru, u kutiji [HR-H-728493948-02] 14 kapsula u blisteru, u kutiji [HR-H-728493948-03] 28 kapsula u blisteru, u kutiji [HR-H-728493948-04] 30 kapsula u blisteru, u kutiji [HR-H-728493948-05] 56 kapsula u blisteru, u kutiji [HR-H-728493948-06] 60 kapsula u blisteru, u kutiji [HR-H-728493948-07] 90 kapsula u blisteru, u kutiji [HR-H-728493948-08] 100 kapsula u blisteru, u kutiji [HR-H-728493948-09] |
| Manufacturer | TAD Pharma Gmbh, Cuxhaven, Njemačka Krka d.d., Novo mesto, Novo Mesto, Slovenija |
| Marketing Authorisation Holder | Krka - farma d.o.o., Radnička cesta 48, Zagreb, Hrvatska |
| Marketing Authorisation Date | 28.01.2020 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/19-02/124 |
| Registration Number | 381-12-01/38-20-05 |
| Prescription | na recept |
| Type of prescription | ponovljivi recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | N06AX21 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
