Name |
Dolyxan 60 mg tvrde želučanootporne kapsule |
Former Name |
Duloksetin Belupo 60 mg tvrde želučanootporne kapsule |
Marketing Authorisation Number |
HR-H-263079706 |
Active Substance |
duloksetinklorid |
Composition |
jedna kapsula sadrži 60 mg duloksetina (u obliku duloksetinklorida) |
Pharmaceutical Form |
želučanootporna kapsula, tvrda |
Packaging [MA Number for Packaging] |
28 kapsula u blisteru, u kutiji [HR-H-263079706-01]
|
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-530-09/22-02/100 |
Registration Number |
381-12-01/70-22-03 |
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
|