Name |
Paroksetin PharmaS 20 mg filmom obložene tablete |
Marketing Authorisation Number |
HR-H-316087482 |
Active Substance |
paroksetinklorid hemihidrat |
Composition |
jedna filmom obložena tableta sadrži 20 mg paroksetina u obliku paroksetinklorid hemihidrata |
Pharmaceutical Form |
Filmom obložena tableta |
Manufacturer |
PharmaS d.o.o., Zagreb, Hrvatska |
Marketing Authorisation Holder |
PharmaS d.o.o., Radnička cesta 47, Zagreb, Hrvatska |
Marketing Authorisation Date |
29.07.2024 |
MA Period of Validity |
29.07.2029 |
Classification Number |
UP/I-530-09/22-01/134 |
Registration Number |
381-12-01/286-24-20 |
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 |
N06AB05 |
SmPC |
download |
PL |
download |
Public Assessment Report |
download
|
Summary of risk management plan |
download |