| Code | 9786D | ||||||||||
| MA number | EU/1/21/1619/004 | ||||||||||
| Product Form: | tbl flm 14x1x50 mg/850 mg (blis.PVC/PE/PVDC/Al jednotk.bal.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Mylan Pharmaceuticals Limited, Ireland | ||||||||||
| Therapeutic Class: | 18 - ANTIDIABETICA (VRÁTANE INZULÍNU) | ||||||||||
| ATC: | 
                
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| Shelf life: | 24 | ||||||||||
| Route of admin.: | Oral use | 
| Prescription Status: | Medicinal product subject to medical prescription. | 
| Legal basis: | Article 10(1) generic application | 
| MA issued: | 16.02.2022 | 
| Validity: | 16.02.2027 | 
| SmPC + PL: | 
                                                 | 
                
| Safety feature | Yes | 
| Data update: | 04.03.2022 |