Oftidorix PF 20 mg/ml + 5 mg/ml, kapi za oko, otopina
| Name | Oftidorix PF 20 mg/ml + 5 mg/ml, kapi za oko, otopina |
|---|---|
| Marketing Authorisation Number | HR-H-458197035 |
| Active Substance | dorzolamidklorid timololmaleat |
| Composition | jedan ml otopine sadrži 20 mg dorzolamida (u obliku dorzolamidklorida) i 5 mg timolola (u obliku timololmaleata) |
| Pharmaceutical Form | kapi za oko, otopina |
| Manufacturer | Pharmathen S.A., Pallini Attiki, Grčka Excelvision, Annonay, Francuska |
| Marketing Authorisation Holder | Bausch + Lomb Ireland Limited, 3013 Lake Drive, Citywest Business Campus, Dublin 24, Irska |
| Marketing Authorisation Date | 02.09.2022 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/20-02/121 |
| Registration Number | 381-12-01/154-22-44 |
| 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 | S01ED51 |
| Marketing status | Marketed |
| Shortage status | Actual |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |