| Code | 2889E | ||||||||||
| MA number | 18/0042/23-S | ||||||||||
| Product Form: | tbl flm 56x50 mg (blis.Al/PVC/PE/PVDC) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | BAUSCH HEALTH IRELAND LIMITED, Ireland | ||||||||||
| Therapeutic Class: | 18 - ANTIDIABETICA (VRÁTANE INZULÍNU) | ||||||||||
| ATC: |
|
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| Shelf life: | 30 | ||||||||||
| Container: | blister Al/PVC/PE/PVDC | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 04.03.2023 |
| Validity: | 04.03.2028 |
| SPC: |
SPC_MIFOGLAME_50mg_01 2023.pdf
|
| PIL: |
PIL_MIFOGLAME_50mg_100mg_01 2023.pdf
|
| Safety feature | Yes |
| Data update: | 27.03.2023 |
