| Code | 2968D | ||||||||||
| MA number | 06/0374/19-S | ||||||||||
| Product Form: | sol por 1x180 ml (fľ.PET jantárová+1 dáv.pipeta+2 dáv.poháre) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | AS KALCEKS, Latvia | ||||||||||
| Therapeutic Class: | 06 - PSYCHOSTIMULANTIA (NOOTROPNE LIEČ., ANALEPTIKA) | ||||||||||
| ATC: |
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| Shelf life: | 60 | ||||||||||
| Container: | bottle polyethylene terephtalate (PET) | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to special medical prescription with skew blue stripe. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 27.12.2019 |
| SPC: |
SPC_Sodium oxybate Kalceks_04_2024.pdf
|
| PIL: |
PIL_Sodium oxybate Kalceks_04_2024.pdf
|
| Dokument: |
Sodium-oxybate-Kalceks_Karta pacienta.pdf
|
| Dokument: |
Sodium-oxybate-Kalceks_Informačný list k často kladeným otázkam.pdf
|
| Dokument: |
Sodium-Oxybate-Kalceks_Prirucka pacienta.pdf
|
| Dokument: |
Sodium-oxybate-Kalceks_Formulár na začatie liečby a následné kontroly.pdf
|
| Safety feature | Yes |
| Data update: | 26.04.2024 |
