| Name |
Dolyxan 30 mg tvrde želučanootporne kapsule |
| Former Name |
Duloksetin Belupo 30 mg tvrde želučanootporne kapsule |
| Marketing Authorisation Number |
HR-H-921648353 |
| Active Substance |
duloksetinklorid |
| Composition |
jedna kapsula sadrži 30 mg duloksetina (u obliku duloksetinklorida) |
| Pharmaceutical Form |
želučanootporna kapsula, tvrda |
| Packaging [MA Number for Packaging] |
28 kapsula u blisteru, u kutiji [HR-H-921648353-01]
|
| 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 |
05.10.2022 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/22-02/99 |
| Registration Number |
381-12-01/70-22-04 |
| 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
|
| Summary of risk management plan |
download |
