| Code | 5681D | ||||||||||
| MA number | 18/0227/20-S | ||||||||||
| Product Form: | tbl plg 84x1000 mg (blis.PVC/PVDC/Al) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Zentiva, k.s., Czechia | ||||||||||
| Therapeutic Class: | 18 - ANTIDIABETICA (VRÁTANE INZULÍNU) | ||||||||||
| ATC: |
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| Shelf life: | 36 | ||||||||||
| Container: | blister PVC/PVDC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 20.10.2020 |
| PIL: |
PIL_Mirovian XR 500 mg, 750 mg,1000 mg tbl plg_09_2025.pdf
|
| SPC: |
SPC_Mirovian XR 1000 mg tbl plg_09_2025.pdf
|
| Safety feature | Yes |
| Data update: | 05.11.2024 |
