| Name |
Duloksetin Pliva 60 mg želučanootporne tvrde kapsule |
| Marketing Authorisation Number |
HR-H-406299508 |
| Active Substance |
duloksetinklorid |
| Composition |
svaka kapsula sadrži duloksetinklorid koji odgovara 60 mg duloksetina |
| Pharmaceutical Form |
želučanootporna kapsula, tvrda |
| Manufacturer |
Balkanpharma - Dupnitsa AD, Dupnitsa, Bugarska |
| Marketing Authorisation Holder |
Pliva Hrvatska d.o.o., Prilaz baruna Filipovića 25, Zagreb, Hrvatska |
| Marketing Authorisation Date |
31.05.2024 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/23-02/178 |
| Registration Number |
381-12-01/171-24-02 |
| Prescription |
Medicinal product subject to medical prescription |
| Type of prescription |
Medicinal product on medical prescription for renewable delivery
|
| Distribution |
Supply through pharmacies (community) |
| Advertising to general public |
not allowed |
| ATC Code |
N06AX21 |
| Marketing status |
Marketed |
| Shortage status |
No shortage |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
