| Code | 5903B | ||||||||||
| MA number | EU/1/15/1020/001 | ||||||||||
| Product Form: | tbl flm 180x150 mg (fľ.HDPE) | ||||||||||
| MA Status: | Ev - Valid centralised marketing authorisation under exceptional circumstances | ||||||||||
| Type of procedure: | EU Orphan | ||||||||||
| MAH, country: | Chiesi Farmaceutici S.p.A., Italy | ||||||||||
| Therapeutic Class: | 06 - PSYCHOSTIMULANTIA (NOOTROPNE LIEČ., ANALEPTIKA) | ||||||||||
| ATC: |
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| Shelf life: | 60 | ||||||||||
| Container: | bottle HDPE | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 08.09.2015 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 11.08.2025 |
