| Code | 0202F | ||||||||||
| MA number | 18/0202/25-S | ||||||||||
| Product Form: | tbl flm 28x1x5 mg (blis.OPA/Al/PVC/Al) - jednotk.bal. | ||||||||||
| 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 OPA/Al/PVC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 09.07.2025 |
| Validity: | 09.07.2030 |
| SPC: |
SPC_Zyfoqam_tbl flm_06/2025_REG.pdf
|
| PIL: |
PIL_Zyfoqam_tbl flm_06/2025_REG.pdf
|
| Safety feature | Yes |
| Data update: | 10.07.2025 |
