| Name |
Bromazepam INN-FARM 1,5 mg tablete |
| Marketing Authorisation Number |
HR-H-054867120 |
| Active Substance |
bromazepam |
| Composition |
jedna tableta sadrži 1,5 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-530-09/21-01/344 |
| Registration Number |
381-12-01/70-23-06 |
| Prescription |
Medicinal product subject to medical prescription |
| Type of prescription |
Medicinal product on medical prescription for non-renewable delivery
|
| Distribution |
Supply through pharmacies (community) |
| Advertising to general public |
not allowed |
| ATC Code |
N05BA08 |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
