Betaklav 400 mg/57 mg u 5 ml prašak za oralnu suspenziju
| Name | Betaklav 400 mg/57 mg u 5 ml prašak za oralnu suspenziju |
|---|---|
| Marketing Authorisation Number | HR-H-138865152 |
| Active Substance | amoksicilin trihidrat kalijev klavulanat |
| Composition | 5 ml suspenzije sadrži 400 mg amoksicilina (u obliku amoksicilin trihidrata) i 57 mg klavulanske kiseline (u obliku kalijevog klavulanata) |
| Pharmaceutical Form | prašak za oralnu suspenziju |
| Manufacturer | Krka d.d., Novo mesto, Novo Mesto, Slovenija TAD Pharma Gmbh, Cuxhaven, Njemačka |
| Marketing Authorisation Holder | Krka - farma d.o.o., Radnička cesta 48, Zagreb, Hrvatska |
| Marketing Authorisation Date | 04.01.2021 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/19-02/194 |
| Registration Number | 381-12-01/38-21-03 |
| Prescription | na recept |
| Type of prescription | neponovljivi recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | J01CR02 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
