| Code | 4065D | ||||||||||
| MA number | 57/0075/20-S | ||||||||||
| Product Form: | tbl flm 20x2 mg (blis.PVC/PVDC/PVC/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| Therapeutic Class: | 57 - HYPNOTICA, SEDATIVA | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - known active substance |
| MA issued: | 17.04.2020 |
| Validity: | 17.04.2025 |
| MA renewed: | Renewal application submitted |
| Pediatric contraindication: | Yes |
| PIL: |
PIL_Esogno 1 2 3 mg tbl flm_apríl_2020.docx
|
| SPC: |
SPC_Esogno_tbl flm_01.2022.pdf
|
| Safety feature | Yes |
| Data update: | 19.01.2022 |
