| Code | 1391E | ||||||||||
| MA number | 18/0176/22-S | ||||||||||
| Product Form: | tbl flm 168x50 mg/850 mg (blis.PVC/PVDC/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Egis Pharmaceuticals PLC, Hungary | ||||||||||
| Therapeutic Class: | 18 - ANTIDIABETICA (VRÁTANE INZULÍNU) | ||||||||||
| ATC: | 
                
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| Shelf life: | 24 | ||||||||||
| Container: | blister PVC/PVDC/Al | ||||||||||
| Route of admin.: | Oral use | 
| Prescription Status: | Medicinal product subject to medical prescription. | 
| Legal basis: | Article 10(1) generic application | 
| MA issued: | 15.07.2022 | 
| Validity: | 15.07.2027 | 
| PIL: | 
            
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| SPC: | 
            
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| Safety feature | Yes | 
| Data update: | 22.07.2022 |