| Code | 8389C | ||||||||||
| MA number | 19/0213/18-S | ||||||||||
| Product Form: | tbl slg 28x4 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_Bupensanduou sublingvalne tablety_03_2025.pdf
|
| SPC: |
SPC_Bupensanduou sublingvalne tablety_03_2025.pdf
|
| Safety feature | Yes |
| Data update: | 02.05.2023 |
