Code | 4056D | ||||||||||
MA number | 57/0074/20-S | ||||||||||
Product Form: | tbl flm 28x1 mg (blis.OPA/Al/PVC/Al) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | G.L. Pharma GmbH, Austria | ||||||||||
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: | 18.01.2022 |