| Code | 1605D | ||||||||||
| MA number | EU/1/19/1360/002 | ||||||||||
| Product Form: | sol inj 4 (4x1)x1,5 ml/285 mg (striek.inj.napl.skl.) | ||||||||||
| MA Status: | Ex - Conditional centralised marketing authorisation | ||||||||||
| Type of procedure: | EU Orphan | ||||||||||
| MAH, country: | Akcea Therapeutics Ireland Ltd, Ireland | ||||||||||
| Therapeutic Class: | 31 - HYPOLIPIDAEMICA | ||||||||||
| ATC: |
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| Shelf life: | 60 | ||||||||||
| Container: | pre-filled syringe | ||||||||||
| Route of admin.: | Subcutaneous use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 03.05.2019 |
| Validity: | 08.05.2026 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 14.04.2025 |
