Meropenem Qilu 1000 mg prašak za otopinu za injekciju/infuziju
| Name | Meropenem Qilu 1000 mg prašak za otopinu za injekciju/infuziju |
|---|---|
| Marketing Authorisation Number | HR-H-871429230 |
| Active Substance | meropenem trihidrat |
| Composition | svaka bočica sadrži 1000 mg meropenema u obliku meropenem trihidrata |
| Pharmaceutical Form | Prašak za otopinu za injekciju / infuziju |
| Manufacturer | Kymos S.L., Cerdanyola del Valles, Barcelona, Španjolska Unifarma SIA, Riga, Latvija Eurofins Analytical Services Hungary Kft., Budimpešta, Mađarska |
| Marketing Authorisation Holder | Qilu Pharma Spain S.L., Paseo de la Castellana 40, planta 8, Madrid, Španjolska |
| Marketing Authorisation Date | 15.12.2022 |
| MA Period of Validity | 15.12.2027 |
| Classification Number | UP/I-530-09/21-01/207 |
| Registration Number | 381-12-01/171-22-09 |
| 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 | J01DH02 |
| Marketing status | Marketed |
| Shortage status | No shortage |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
