Duloksetin STADA 120 mg tvrde želučanootporne kapsule
Name | Duloksetin STADA 120 mg tvrde želučanootporne kapsule |
---|---|
Marketing Authorisation Number | HR-H-631781469 |
Active Substance | duloksetinklorid |
Composition | jedna tvrda želučanootporna kapsula sadrži 120 mg duloksetina (u obliku duloksetinklorida) |
Pharmaceutical Form | Želučanootporna kapsula, tvrda |
Manufacturer | STADA Arzneimittel GmbH, Beč, Austrija Clonmel Healthcare Ltd., Clonmel, Co. Tipperary, Irska Centrafarm Services B.V., Breda, Nizozemska STADA Arzneimittel AG, Bad Vilbel, Njemačka |
Marketing Authorisation Holder | Stada d.o.o., Hercegovačka 14, Zagreb, Hrvatska |
Marketing Authorisation Date | 28.09.2022 |
MA Period of Validity | 28.09.2027 |
Classification Number | UP/I-530-09/21-01/58 |
Registration Number | 381-12-01/38-22-04 |
Prescription | Medicinal product subject to medical prescription |
Type of prescription | ponovljivi recept |
Distribution | Supply through pharmacies (community) |
Advertising to general public | not allowed |
ATC Code | N06AX21 |
Marketing status | nije stavljeno u promet |
SmPC | download |
PL | download |
Public Assessment Report | download |
Summary of risk management plan | download |