| 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: |
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| Safety feature | Yes |
| Data update: | 07.12.2022 |