Code | 8388C | ||||||||||
MA number | 19/0213/18-S | ||||||||||
Product Form: | tbl slg 7x4 mg/1 mg (blis.OPA/Al/PVC/Al) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | G.L. Pharma GmbH, Austria | ||||||||||
Therapeutic Class: | 19 - ANTIDOTA, DETOXICANTIA | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | blister OPA/Al/PVC/Al | ||||||||||
Route of admin.: | Sublingual use |
Prescription Status: | Medicinal product subject to special medical prescription with skew blue stripe. |
Legal basis: | Article 10(3) hybrid application |
MA issued: | 11.07.2018 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
PIL: | PIL_Bupensanduo sublingválne tablety_04_2023.pdf |
SPC: | SPC_Bupensanduo sublingválne tablety_04_2023.pdf |
Safety feature | Yes |
Data update: | 02.05.2023 |