Code | 7336C | ||||||||||
MA number | 65/0100/18-S | ||||||||||
Product Form: | sol inj 10x1 ml (amp.skl.) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
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 | ||||||||||
Route of admin.: | Subcutaneous, intramuscular and intravenous use |
Prescription Status: | Medicinal product subject to special medical prescription with skew blue stripe. |
Legal basis: | Article 10(1) generic application |
MA issued: | 19.03.2018 |
SPC: | SPC_Morphine Kalceks 10 mg-ml injekčný roztok_01.2024.pdf |
PIL: | PIL_Morphine Kalceks 10 mg-ml injekčný roztok_01.2024.pdf |
Safety feature | Yes |
Data update: | 01.07.2020 |