| Code | 6589E | ||||||||||
| MA number | EU/1/24/1815/011 | ||||||||||
| Product Form: | sol ira 1x3 ml/2100 jednotiek (pero napl.skl.FlexTouch + 13 ihiel) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Novo Nordisk A/S, Denmark | ||||||||||
| Therapeutic Class: | 18 - ANTIDIABETICA (VRÁTANE INZULÍNU) | ||||||||||
| ATC: |
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| Shelf life: | 30 | ||||||||||
| Container: | glass pre-filled pen | ||||||||||
| Route of admin.: | Subcutaneous use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 17.05.2024 |
| Validity: | 17.05.2029 |
| SmPC + PL: |
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| Safety feature | Yes |
| Data update: | 13.06.2024 |