| Code | 3165C | ||||||||||
| MA number | EU/1/15/1016/007 | ||||||||||
| Product Form: | sol inj 3 (3x1)x3,5 ml/420 mg (náplň plast.+3 (3x1) minidávk.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Amgen Europe B.V., Netherland | ||||||||||
| Therapeutic Class: | 31 - HYPOLIPIDAEMICA | ||||||||||
| ATC: |
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| Shelf life: | 24 | ||||||||||
| Route of admin.: | Subcutaneous use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 17.02.2017 |
| SmPC + PL: |
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| Safety feature | Yes |
| Data update: | 27.04.2020 |