| Code | 9815C | ||||||||||
| MA number | 18/0397/18-S | ||||||||||
| Product Form: | tbl flm 30x50 mg/850 mg (blis.OPA/Al/PVC/Al) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| Therapeutic Class: | 18 - ANTIDIABETICA (VRÁTANE INZULÍNU) | ||||||||||
| ATC: |
|
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| Shelf life: | 24 | ||||||||||
| 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: | 12.12.2018 |
| Validity: | 12.12.2023 |
| PIL: |
PIL_Agnis Combi 50 mg 850 mg tbl flm_december_2018.docx
|
| SPC: |
SPC_Agnis Combi 50 mg_850 mg_03.2020.doc
|
| Safety feature | Yes |
| Data update: | 31.07.2023 |
