| Code | 0665E | ||||||||||
| MA number | EU/1/22/1638/004 | ||||||||||
| Product Form: | tbl flm 30x50 mg (blis. PVC/PVDC/PVC/Al) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Idorsia Pharmaceuticals Deutschland GmbH, Germany | ||||||||||
| Therapeutic Class: | 57 - HYPNOTICA, SEDATIVA | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Container: | blister PVC/PVDC/PVC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 29.04.2022 |
| Validity: | 29.04.2027 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 27.01.2025 |
