| Code | 7910D | ||||||||||
| MA number | 18/0172/21-S | ||||||||||
| Product Form: | tbl 336x50 mg (blis.PA/Al/PVC/Al) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Vipharm S.A., Poland | ||||||||||
| Therapeutic Class: | 18 - ANTIDIABETICA (VRÁTANE INZULÍNU) | ||||||||||
| ATC: | 
                
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| Shelf life: | 36 | ||||||||||
| Container: | blister PA/Al/PVC/Al | ||||||||||
| Route of admin.: | Oral use | 
| Prescription Status: | Medicinal product subject to medical prescription. | 
| Legal basis: | Article 10(1) generic application | 
| MA issued: | 28.06.2021 | 
| Validity: | 28.06.2026 | 
| SPC: | 
            
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| PIL: | 
            
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| Safety feature | Yes | 
| Data update: | 04.08.2025 |