| Name |
Areversin 100 mg/ml otopina za injekciju |
| Marketing Authorisation Number |
HR-H-939767824 |
| Active Substance |
sugamadeksnatrij |
| Composition |
1 ml otopine sadrži 100 mg sugamadeksa (u obliku 108,8 mg sugamadeksnatrija) |
| Pharmaceutical Form |
otopina za injekciju |
| Manufacturer |
Pharmaselect International Beteiligungs GmbH, Beč, Austrija |
| Marketing Authorisation Holder |
Pharmaselect International Beteiligungs GmbH, Ernst-Melchior Gasse 20, Beč, Austrija |
| Marketing Authorisation Date |
08.12.2023 |
| MA Period of Validity |
08.12.2028 |
| Classification Number |
UP/I-530-09/22-01/154 |
| Registration Number |
381-12-01/70-23-09 |
| 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 |
V03AB35 |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
