Meropenem Sandoz 1000 mg prašak za otopinu za injekciju/infuziju
| Name | Meropenem Sandoz 1000 mg prašak za otopinu za injekciju/infuziju |
|---|---|
| Marketing Authorisation Number | HR-H-670362322 |
| Active Substance | meropenem trihidrat |
| Composition | Svaka bočica sadrži 1140,8 mg meropenem trihidrata što odgovara 1000 mg bezvodnog meropenema |
| Pharmaceutical Form | Prašak za otopinu za injekciju / infuziju |
| Manufacturer | Salutas Pharma GmbH, Barleben, Njemačka
Lek Pharmaceuticals d.d., Ljubljana, Slovenija |
| Marketing Authorisation Holder | Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska |
| Marketing Authorisation Date | 14.07.2023 |
| MA Period of Validity | 14.07.2028 |
| Classification Number | UP/I-530-09/20-01/324 |
| Registration Number | 381-12-01/286-23-06 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | ograničeni recept |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | J01DH02 |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
