| Code | 35201 | ||||||||||
| MA number | 57/0209/06-S | ||||||||||
| Product Form: | tbl obd 10x50 mg (blis.PVC/PVDC/Al) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | National | ||||||||||
| Therapeutic Class: | 57 - HYPNOTICA, SEDATIVA | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Container: | blister PVC/PVDC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10a well-established use application |
| MA issued: | 09.06.2006 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric contraindication: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Calmaben_10.2023.pdf
|
| SPC: |
SPC_Calmaben_10.2023.pdf
|
| Safety feature | Yes |
| Data update: | 08.06.2018 |
