Code | 2514E | ||||||||||
MA number | EU/1/22/1694/004 | ||||||||||
Product Form: | tbl plg 30x2 mg (blis.PVC/PVDC/Al) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | RAD Neurim Pharmaceuticals EEC SARL, France | ||||||||||
Therapeutic Class: | 57 - HYPNOTICA, SEDATIVA | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | blister PVC/PVDC/Al | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10c informed consent application |
MA issued: | 07.11.2022 |
Validity: | 07.11.2027 |
SmPC + PL: | European Medicines Agency's database |
Safety feature | Yes |
Data update: | 07.12.2022 |