Code | 0577E | ||||||||||
MA number | 41/0108/22-S | ||||||||||
Product Form: | con inf 4x5ml/12,5 mg (liek.skl.inj.) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
Therapeutic Class: | 41 - CARDIACA | ||||||||||
ATC: |
|
||||||||||
Shelf life: | 18 | ||||||||||
Container: | vial | ||||||||||
Route of admin.: | Intravenous use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 16.05.2022 |
Validity: | 16.05.2027 |
Pediatric warnings: | Yes |
PIL: | PIL_Levosimendan Kalceks 2,5 mg_ml koncentrát na infúzny roztok_04_2022.pdf |
SPC: | SPC_Levosimendan Kalceks 2,5 mg/ml koncentrát na infúzny roztok_11_2022.pdf |
Safety feature | Yes |
Data update: | 07.11.2022 |