| Code | 1098E | ||||||||||
| MA number | EU/1/11/709/006 | ||||||||||
| Product Form: | sol ora 2x1 ml/5 mg (striek.orálna napln.PP) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Neuraxpharm Pharmaceuticals, S.L. , Spain | ||||||||||
| Therapeutic Class: | 57 - HYPNOTICA, SEDATIVA | ||||||||||
| ATC: |
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| Shelf life: | 24 | ||||||||||
| Container: | pre-filled oral syringe PP | ||||||||||
| Route of admin.: | Oromucosal use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 05.09.2011 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 28.05.2022 |
