Code | 28312 | ||||||||||
MA number | 57/0057/99-S | ||||||||||
Product Form: | tbl flm 20x7,5 mg (blis.PVC/Al) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | National | ||||||||||
MAH, country: | Zentiva a.s., Slovakia | ||||||||||
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 subject to medical prescription. |
Legal basis: | Article 10a well-established use application |
MA issued: | 01.06.1999 |
Pediatric contraindication: | Yes |
Pediatric warnings: | Yes |
SPC: | SPC_Zopiclon 7 5-SL_08.2019.docx |
PIL: | PIL_Zopiclon 7 ,5-SL_08.2019.docx |
Safety feature | Yes |
Data update: | 02.02.2018 |