Code | 3104D | ||||||||||
MA number | 39/0385/19-S | ||||||||||
Product Form: | sol ijf 100x10 ml (amp.skl.) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | AS KALCEKS, Latvia | ||||||||||
Therapeutic Class: | 39 - SOLI A IONTY PRO P.O. A PARENT. APLIKÁCIU | ||||||||||
ATC: |
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Shelf life: | 60 | ||||||||||
Container: | glass ampoule | ||||||||||
Route of admin.: | Subcutaneous, intramuscular and intravenous use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10a well-established use application |
MA issued: | 03.01.2020 |
Validity: | 03.01.2025 |
MA renewed: | Renewal application submitted |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
PIL: | PIL_Magnesium sulfate Kalceks_04_2022.pdf |
SPC: | SPC_Magnesium sulfate Kalceks_08_2022.pdf |
Safety feature | Yes |
Data update: | 23.08.2022 |