| MR编号 | SI/H/0173/001 |
|---|
| 药品名称 | Imipenem/cilastatin AptaPharma 500 mg/500 mg powder for solution for infusion |
|---|
| 活性成分 | - cilastatin 500.0 mg
- imipenem 500.0 mg
|
|---|
| 剂型 | Powder for solution for infusion |
|---|
| 上市许可持有人 | Apta Medica Internacional d.o.o.
Likozarjeva 6
1000 Ljubljana
Slovenia |
|---|
| 参考成员国 - 产品名称 | Slovenia (SI) Imipenem/Cilastatin AptaPharma 500 mg/500 mg prašak za raztopino za infundiranje |
|---|
| 互认成员国 - 产品名称 | - Poland (PL)
- Bulgaria (BG)
Imipenem/cilastatin AptaPharma - Czechia (CZ)
Imipenem/Cilastatin AptaPharma 500 mg/500 mg prášek pro infuzní roztok - Romania (RO)
Imipenem/Cilastatin AptaPharma 500 mg/500 mg pulbere pentru soluţie perfuzabilă - Cyprus (CY)
Imipenem/cilastatin AptaPharma 500 mg/500 mg powder for solution for infusion - Malta (MT)
Imipenem/Cilastatin AptaPharma Pdr for Soln for Infusion 500mg - Slovakia (SK)
- Austria (AT)
Imipenem/Cilastatin AptaPharma 500 mg/500 mg Pulver zur Herstellung einer Infusionslösung - Hungary (HU)
IMIPENEM/CILASTATIN APTAPHARMA 500 mg/500 mg por oldatos infúzióhoz - Croatia (HR)
Imipenem/cilastatin AptaPharma 500 mg/500 mg prašak za otopinu za infuziju
|
|---|
| 许可日期 | 2017/09/13 |
|---|
| 最近更新日期 | 2022/10/13 |
|---|
| 药物ATC编码 | - J01DH51 imipenem and cilastatin
| 申请类型 | - TypeLevel1：Known Active Substance
- TypeLevel2：Initial Application
- TypeLevel3：Generic Art 10.1 and 10.2 Dir 2001/83/EC
- TypeLevel4：Chemical Substance
- TypeLevel5：Prescription Only
|
|---|
| 附件文件下载 | |
|---|
| 市场状态 | Positive |
|---|
|
|---|