| Code | 4198E | ||||||||||
| MA number | 19/0192/23-S | ||||||||||
| Product Form: | sol inj 1x2 ml/200 mg (liek.inj.skl.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | AS KALCEKS, Latvia | ||||||||||
| Therapeutic Class: | 19 - ANTIDOTA, DETOXICANTIA | ||||||||||
| 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: | 29.08.2023 |
| Validity: | 29.08.2028 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| SPC: |
SPC_Sugammadex Kalceks 100 mg_ml injekčný roztok_08_2023.pdf
|
| PIL: |
PIL_Sugammadex Kalceks 100 mg_ml injekčný roztok_08_2023.pdf
|
| Safety feature | Yes |
| Data update: | 08.09.2023 |
