Code | 7818B | ||||||||||
MA number | 57/0700/94-S | ||||||||||
Product Form: | tbl obd 2x10x35 mg/17,5 mg/17,5 mg (blis. PVC/Al) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | National | ||||||||||
MAH, country: | Zentiva k.s., Czechia | ||||||||||
Therapeutic Class: | 57 - HYPNOTICA, SEDATIVA | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | blister PVC/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: | 28.10.1994 |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
PIL: | PIL_Persen_08.2021.pdf |
SPC: | SPC_PERSEN_09.2023.pdf |
Safety feature | No |
Data update: | 05.09.2023 |