| Code | 5207C | ||||||||||
| MA number | 18/0281/17-S | ||||||||||
| Product Form: | tbl flm 360x50 mg/850 mg (blis.Al/Al-OPA/Al/PVC) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | MEDOCHEMIE Ltd., Cyprus | ||||||||||
| Therapeutic Class: | 18 - ANTIDIABETICA (VRÁTANE INZULÍNU) | ||||||||||
| ATC: |
|
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| Shelf life: | 24 | ||||||||||
| Container: | blister Al/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 27.09.2017 |
| PIL: |
PIL_DALTEX flm tbl_08_2025.pdf
|
| SPC: |
SPC_DALTEX flm tbl_08_2025.pdf
|
| Safety feature | Yes |
| Data update: | 17.03.2023 |
