| Code | 7085D | ||||||||||
| MA number | EU/1/20/1506/006 | ||||||||||
| Product Form: | sol inj 10x3 ml/300 U (pero napl.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Biosimilar Collaborations Ireland Limited, Ireland | ||||||||||
| Therapeutic Class: | 18 - ANTIDIABETICA (VRÁTANE INZULÍNU) | ||||||||||
| ATC: |
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| Shelf life: | 30 | ||||||||||
| Route of admin.: | Subcutaneous use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(4) similar biological application |
| MA issued: | 05.02.2021 |
| Validity: | 05.02.2026 |
| SmPC + PL: |
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| Safety feature | Yes |
| Data update: | 08.09.2023 |