| Name |
Bysimin 20 mg/ml otopina za injekciju |
| Marketing Authorisation Number |
HR-H-761806946 |
| Active Substance |
hioscinijev butilbromid |
| Composition |
svaka ampula od 1 ml sadrži 20 mg hioscinijevog butilbromida |
| Pharmaceutical Form |
otopina za injekciju |
| Manufacturer |
Medochemie Ltd., Limassol, Cipar |
| Marketing Authorisation Holder |
Medochemie Ltd., Constatinoupoleos Str. 1-10, Limassol, Cipar |
| Marketing Authorisation Date |
13.12.2022 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/21-02/88 |
| Registration Number |
381-12-01/171-22-03 |
| Prescription |
Medicinal product subject to medical prescription |
| Type of prescription |
Medicinal product subject to restricted medical prescription
|
| Distribution |
Supply through pharmacies (community) |
| Advertising to general public |
not allowed |
| ATC Code |
A03BB01 |
| Marketing status |
Marketed |
| Shortage status |
No shortage |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
