Code | 1566D | ||||||||||
MA number | 65/0162/19-S | ||||||||||
Product Form: | sol ijf 10x5 ml (amp.skl.) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Mutual recognition procedure | ||||||||||
MAH, country: | AS KALCEKS, Latvia | ||||||||||
Therapeutic Class: | 65 - ANALGETICA - ANODYNA | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | glass ampoule |
Prescription Status: | Medicinal product subject to special medical prescription with skew blue stripe. |
Legal basis: | Article 10(3) hybrid application |
MA issued: | 29.05.2019 |
Validity: | 29.05.2024 |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
SPC: | SPC_Maracex 20 mg_ml injekčný_infúzny roztok_07.2022.pdf |
PIL: | PIL_Maracex 20 mg_ml injekčný_infúzny roztok_07.2022.pdf |
Safety feature | Yes |
Data update: | 23.07.2019 |