| Code | 3697E | ||||||||||
| MA number | 44/0227/21-S | ||||||||||
| Product Form: | tbl flm 112x500 mg (blis.PVC/PVDC/Al - priehľadné) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Glenmark Pharmaceuticals s.r.o., Czechia | ||||||||||
| Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
| ATC: |
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| Shelf life: | 24 | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 26.08.2021 |
| Validity: | 26.08.2026 |
| MA renewed: | Renewal application submitted |
| SPC: |
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| PIL: |
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| Safety feature | Yes |
| Data update: | 06.06.2023 |