| Code | 2721D | ||||||||||
| MA number | 57/0338/19-S | ||||||||||
| Product Form: | tbl 30x5 mg (blis.PVC/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| Therapeutic Class: | 57 - HYPNOTICA, SEDATIVA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Container: | blister PVC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10a well-established use application |
| MA issued: | 22.11.2019 |
| Validity: | 22.11.2024 |
| MA renewed: | Renewal application submitted |
| PIL: |
PIL_Melatonin Vitabalans 3 mg 5 mg tablety_R_06.2021.pdf
|
| SPC: |
SPC_Melatonin Vitabalans_07.2022.pdf
|
| Safety feature | Yes |
| Data update: | 13.07.2022 |
