Name |
Bromazepam INN-FARM 3 mg tablete |
Marketing Authorisation Number |
HR-H-123508921 |
Active Substance |
bromazepam |
Composition |
jedna tableta sadrži 3 mg bromazepama |
Pharmaceutical Form |
Tableta |
Manufacturer |
Fine Foods & Pharmaceuticals NTM S.p.A., Brembate (BG), Italija |
Marketing Authorisation Holder |
INN-FARM d.o.o., Maleševa ulica 14, Ljubljana, Slovenija |
Marketing Authorisation Date |
22.05.2023 |
MA Period of Validity |
22.05.2028 |
Classification Number |
UP/I-530-09/21-01/345 |
Registration Number |
381-12-01/70-23-05 |
Prescription |
Medicinal product subject to medical prescription |
Type of prescription |
neponovljivi recept
|
Distribution |
Supply through pharmacies (community) |
Advertising to general public |
not allowed |
ATC Code |
N05BA08 |
Marketing status |
nije stavljeno u promet |
SmPC |
download |
PL |
download |
Public Assessment Report |
download
|
Summary of risk management plan |
download |