Code | 00046 | ||||||||||
MA number | 57/0151/12-S | ||||||||||
Product Form: | tbl flm 10x10 mg (blis.PVC/Al) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | National | ||||||||||
MAH, country: | Neuraxpharm Bohemia s.r.o., 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 subject to medical prescription. |
Legal basis: | Article 10a well-established use application |
MA issued: | 22.03.2012 |
SPC: |
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PIL: |
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Safety feature | Yes |
Data update: | 15.05.2018 |