| Code | 1276E | ||||||||||
| MA number | 18/0175/22-S | ||||||||||
| Product Form: | tbl flm 120x50mg/1000 mg (blis.PVC/PE/PVDC//Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Gedeon Richter Plc., Hungary | ||||||||||
| Therapeutic Class: | 18 - ANTIDIABETICA (VRÁTANE INZULÍNU) | ||||||||||
| 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 10(1) generic application | 
| MA issued: | 23.06.2022 | 
| Validity: | 23.06.2027 | 
| SPC: | 
            
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| PIL: | 
            
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| Safety feature | Yes | 
| Data update: | 16.02.2023 |