Amoksicilin/klavulanska kiselina Antibiotice 1000 mg/200 mg prašak za otopinu za injekciju/infuziju
| Name | Amoksicilin/klavulanska kiselina Antibiotice 1000 mg/200 mg prašak za otopinu za injekciju/infuziju |
|---|---|
| Marketing Authorisation Number | HR-H-499090429 |
| Active Substance | amoksicilinnatrij kalijev klavulanat |
| Composition | jedna bočica s praškom sadrži 1000 mg amoksicilina (u obliku amoksicilinnatrija) i 200 mg klavulanske kiseline (u obliku kalijevog klavulanata) |
| Pharmaceutical Form | Prašak za otopinu za injekciju / infuziju |
| Manufacturer | Antibiotice S.A., Iasi, Rumunjska |
| Marketing Authorisation Holder | Antibiotice S.A., 1 Valea Lupului Street, Iasi, Rumunjska |
| Marketing Authorisation Date | 13.07.2026 |
| MA Period of Validity | 13.07.2031 |
| Classification Number | UP/I-530-09/26-01/01 |
| Registration Number | 381-12-01/14-26-12 |
| 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 | J01CR02 |
| Marketing status | Never marketed |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
