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PRODUCT DETAIL

Waylivra 285 mg injekčný roztok naplnený v injekčnej striekačke

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:
C CARDIOVASCULAR SYSTEM
C10 Lipid modifying agents
C10A Lipid modifying agents, plain
C10AX Other lipid modifying agents
C10AX18 Volanesorsen
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: 08.05.2025
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 14.03.2024
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