| Code | 1713A | ||||||||||
| MA number | 63/0251/12-S | ||||||||||
| Product Form: | aer ors 1x10 ml (fľ.skl.jant.s dávk.pumpičkou) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | Jazz Pharmaceuticals Ireland Ltd, Ireland | ||||||||||
| Therapeutic Class: | 63 - MYORELAXANTIA | ||||||||||
| ATC: |
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| Shelf life: | 24 | ||||||||||
| Container: | bottle with metering pump | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to special medical prescription with skew blue stripe. |
| Legal basis: | Article 8(3) application - known active substance |
| MA issued: | 12.06.2012 |
| SPC: |
SPC_Sativex orálny roztokový sprej_aer ors_10_2023.pdf
|
| PIL: |
PIL_Sativex orálny roztokový sprej_aer ors_10_2023.pdf
|
| Safety feature | Yes |
| Data update: | 06.10.2023 |
