| Name |
Brivaracetam Accord 50 mg filmom obložene tablete |
| Marketing Authorisation Number |
HR-H-828579914 |
| Active Substance |
brivaracetam |
| Composition |
jedna filmom obložena tableta sadrži 50 mg brivaracetama |
| Pharmaceutical Form |
Filmom obložena tableta |
| Manufacturer |
Holsten Pharma GmbH, Frankfurt am Main , Njemačka |
| Marketing Authorisation Holder |
Accord Healthcare Polska Sp. z o.o., Ul. Tasmowa 7, Mazowieckie, Varšava, Poljska |
| Marketing Authorisation Date |
20.05.2025 |
| MA Period of Validity |
20.05.2030 |
| Classification Number |
UP/I-530-09/24-01/14 |
| Registration Number |
381-12-01/70-25-07 |
| Prescription |
Medicinal product subject to medical prescription |
| Type of prescription |
Medicinal product on medical prescription for renewable delivery
|
| Distribution |
Supply through pharmacies (community) |
| Advertising to general public |
not allowed |
| ATC Code |
N03AX23 |
| Marketing status |
Never marketed |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
