Betoptic 5 mg/ml kapi za oko, otopina
| Name | Betoptic 5 mg/ml kapi za oko, otopina |
|---|---|
| Former Name | Betoptic 0,5 % kapi za oko |
| Marketing Authorisation Number | HR-H-709311743 |
| Active Substance | betaksololklorid |
| Composition | 1 ml otopine sadrži 5 mg betaksolola (u obliku betaksololklorida) |
| Pharmaceutical Form | kapi za oko, otopina |
| Manufacturer | Novartis Pharma GmbH, Nürnberg, Njemačka Novartis Farmacéutica S.A., Barcelona, Španjolska S.A. Alcon-Couvreur N.V., Puurs, Belgija Siegfried El Masnou S.A. , Barcelona , Španjolska Immedica Pharma AB, Stockholm, Švedska |
| Marketing Authorisation Holder | Immedica Pharma AB, Solnavagen 3H, Stockholm, Švedska |
| Marketing Authorisation Date | 15.03.2022 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/14-02/486 |
| Registration Number | 381-12-01/154-22-45 |
| 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 | S01ED02 |
| Marketing status | Marketed |
| Shortage status | No shortage |
| SmPC | download |
| PL | download |
