Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Akcea Therapeutics Ireland Ltd., St. James House, 72 Adelaide Road, Dublin 2, D02 Y017, Ireland
Waylivra 285 mg solution for injection in pre-filled syringe.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). Clear, colourless to slightly yellow solution with a pH of approximately 8 and osmolarity of 363-485 mOsm/kg. |
Each ml contains 200 mg volanesorsen sodium, equivalent to 190 mg volanesorsen.
Each single-dose pre-filled syringe contains 285 mg of volanesorsen in 1.5 ml solution.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Volanesorsen |
Volanesorsen is an antisense oligonucleotide designed to inhibit the formation of apoC-III, a protein that is recognised to regulate both triglyceride metabolism and hepatic clearance of chylomicrons and other triglyceride-rich lipoproteins. |
| List of Excipients |
|---|
|
Sodium hydroxide (for pH adjustment) |
Single-dose, Type I glass pre-filled syringe with a siliconised chlorobutyl rubber stopper and staked needle with shield, filled to deliver 1.5 ml of solution.
Pack sizes of one pre-filled syringe or multipacks containing 4 (4 packs of 1) pre-filled syringes.
Not all pack sizes may be marketed.
Akcea Therapeutics Ireland Ltd., St. James House, 72 Adelaide Road, Dublin 2, D02 Y017, Ireland
EU/1/19/1360/001
EU/1/19/1360/002
Date of first authorisation: 03 May 2019
Date of latest renewal: 14 February 2022
| Drug | Countries | |
|---|---|---|
| WAYLIVRA | Austria, Estonia, France, Ireland, Lithuania, Poland, Romania, United Kingdom |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
