| Code | 4405E | ||||||||||
| MA number | 18/0199/23-S | ||||||||||
| Product Form: | tbl flm 28x50 mg/850 mg (blis.PVC/PE/PVDC/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| 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 PVC/PE/PVDC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 27.09.2023 |
| Validity: | 27.09.2028 |
| SPC: |
SPC_JIVOLAR flm tbl_10_2025.pdf
|
| PIL: |
PIL_JIVOLAR flm tlb_10_2025.pdf
|
| Safety feature | Yes |
| Data update: | 03.10.2023 |
