Code | 07391 | ||||||||||
MA number | 70/0178/98-S | ||||||||||
Product Form: | tbl 30x0,25 mg (blis.Al/PVC/PE/PVDC) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | National | ||||||||||
MAH, country: | KRKA, d.d., Novo mesto, Slovenia | ||||||||||
Therapeutic Class: | 70 - ANXIOLYTICA | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | blister PVC/PE/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: | 07.04.1998 |
PIL: | PIL_Helex_tbl_11.2022.pdf |
SPC: | SPC_Helex_tbl_11.2022.pdf |
Safety feature | Yes |
Data update: | 29.01.2020 |