| Code | 8321C | ||||||||||
| MA number | EU/1/18/1279/003 | ||||||||||
| Product Form: | sus por 1x30 ml/180 mg (fľ.skl.hnedá+1 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: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 03.03.2023 |
