| Code | 9406B | ||||||||||
| MA number | 57/0153/16-S | ||||||||||
| Product Form: | tbl obd 30x441,35 mg (blis.PVC/PVDC/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| Therapeutic Class: | 57 - HYPNOTICA, SEDATIVA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Container: | blister PVC/PVDC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product not subject to medical prescription. |
| Legal basis: | Article 10a well-established use application |
| MA issued: | 20.05.2016 |
| Validity: | 20.05.2021 |
| MA renewed: | Renewal application submitted |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Baldriparan_02.2022.pdf
|
| SPC: |
SPC_Baldriparan_02.2022.pdf
|
| Safety feature | No |
| Data update: | 28.07.2020 |
