Code | 8322C | ||||||||||
MA number | EU/1/18/1279/004 | ||||||||||
Product Form: | sus por 1x30 ml/180 mg (fľ.skl.hnedá+5 ml per.striek.) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU Orphan | ||||||||||
MAH, country: | AMMTeK, France | ||||||||||
Therapeutic Class: | 18 - ANTIDIABETICA (VRÁTANE INZULÍNU) | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | brown glass bottle | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(3) hybrid application |
MA issued: | 24.05.2018 |
SmPC + PL: |
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Safety feature | Yes |
Data update: | 03.03.2023 |