| Name |
Metamizolnatrij hidrat Bausch Health 500 mg filmom obložene tablete |
| Marketing Authorisation Number |
HR-H-821731665 |
| Active Substance |
metamizolnatrij hidrat |
| Composition |
svaka tableta sadrži 500 mg metamizolnatrij hidrata |
| Pharmaceutical Form |
Filmom obložena tableta |
| Manufacturer |
ICN Polfa Rzeszow S.A, Rzeszow, Poljska |
| Marketing Authorisation Holder |
Bausch Health Ireland Limited, 3013 Lake Drive, Citywest Business Campus, Dublin 24, Irska |
| Marketing Authorisation Date |
31.07.2023 |
| MA Period of Validity |
31.07.2028 |
| Classification Number |
UP/I-530-09/22-01/125 |
| Registration Number |
381-12-01/154-23-10 |
| 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 |
N02BB02 |
| Marketing status |
nije stavljeno u promet |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
