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, Croatia, Ireland, Italy, Lithuania, Poland, Romania, United Kingdom |
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