| Code | 6658D | ||||||||||
| MA number | 18/0044/21-S | ||||||||||
| Product Form: | tbl flm 56x50 mg/1000 mg (blis.Al/PVC/PVDC) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Zaklady Farmaceutyczne POLPHARMA SA, Poland | ||||||||||
| Therapeutic Class: | 18 - ANTIDIABETICA (VRÁTANE INZULÍNU) | ||||||||||
| ATC: |
|
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| Shelf life: | 24 | ||||||||||
| Container: | blister Al/PVC/PVDC | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 23.02.2021 |
| Validity: | 23.02.2026 |
| MA renewed: | Renewal application submitted |
| SPC: |
SPC_Metsigletic_02 2021.docx
|
| PIL: |
PIL_Metsigletic_02 2021.docx
|
| Safety feature | Yes |
| Data update: | 09.03.2021 |
