Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: Akcea Therapeutics Ireland Ltd, St. James House, 72 Adelaide Road, Dublin 2, D02 Y017, Ireland
Tegsedi 284 mg solution for injection in pre-filled syringe.
| Pharmaceutical Form |
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Solution for injection (injection). Clear, colourless to pale yellow solution (pH 7.5–8.8). |
Each ml contains 189 mg inotersen (as inotersen sodium).
Each pre-filled syringe contains 284 mg inotersen (as inotersen sodium) in 1.5 mL of solution.
For the full list of excipients, see section 6.1.
| Active Ingredient |
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Inotersen is a 2′-O-2-methoxyethyl (2′-MOE) phosphorothioate antisense oligonucleotide (ASO) inhibitor of human transthyretin (TTR) production. The selective binding of inotersen to the TTR messenger RNA (mRNA) causes the degradation of both mutant and wild type (normal) TTR mRNA. This prevents the synthesis of TTR protein in the liver, resulting in significant reductions in the levels of mutated and wild type TTR protein secreted by the liver into the circulation. |
| List of Excipients |
|---|
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Water for injections |
1.5 mL solution in a clear Type 1 glass pre-filled syringe.
Tray with tear-off lid.
Pack sizes of 1 or 4 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/1/18/1296/001
EU/1/18/1296/002
Date of first authorisation: 06 July 2018
Date of latest renewal: 24 March 2023
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