| Code | 5500D | ||||||||||
| MA number | EU/1/20/1465/001 | ||||||||||
| Product Form: | sol inf 50x1 ml/10 mg (amp.skl.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Gennisium Pharma, France | ||||||||||
| Therapeutic Class: | 06 - PSYCHOSTIMULANTIA (NOOTROPNE LIEČ., ANALEPTIKA) | ||||||||||
| ATC: |
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| Shelf life: | 36 | ||||||||||
| Container: | glass ampoule | ||||||||||
| Route of admin.: | Intravenous and oromucosal use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 19.08.2020 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 25.03.2025 |
