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 | ||||||||||
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 |
Validity: | 10.09.2025 |
SmPC + PL: | European Medicines Agency's database |
Safety feature | Yes |
Data update: | 14.08.2020 |