| Code | 1918E | ||||||||||
| MA number | 41/0074/22-S | ||||||||||
| Product Form: | con inf 4x5 ml/12,5 mg (liek.skl.inj.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Zentiva, k.s., Czechia | ||||||||||
| Therapeutic Class: | 41 - CARDIACA | ||||||||||
| ATC: |
|
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| Shelf life: | 24 | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 30.03.2022 |
| Validity: | 30.03.2027 |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Levosimendan Zentiva_con inf_08_2022.pdf
|
| PIL: |
PIL_Levosimendan Zentiva_con inf_11_2023.pdf
|
| Safety feature | Yes |
| Data update: | 24.08.2022 |
