Tegsedi
- INN
- inotersen
- Forms
- Solution for injection in pre-filled syringe
- Alternatives
- Yes
What is this? Tegsedi is a medicine given as an injection. It helps people with a rare nerve problem.
What's happening? There is not enough Tegsedi in the EU right now. Other similar medicines are available.
Does this affect me? If you use Tegsedi, your supply may be limited. Ask your pharmacist or doctor about other options.
What should I do? Talk to your pharmacist or doctor before changing your medicine. Do not stop without advice.
🤖 Această prezentare simplificată este generată automat din comunicatul oficial al agenției folosind inteligență artificială. Este doar pentru informare generală — nu reprezintă sfaturi medicale. Pentru decizii privind sănătatea dumneavoastră, consultați întotdeauna un farmacist sau un medic și citiți sursa oficială de mai jos.
📋 Din comunicatul oficial al agenției
Actualizat 3 săptămâni în urmă- Prima publicare
- 03/07/2026
- Medicamentele afectate
- Tegsedi
- Stare deficit
- Shortage ongoing
- Disponibilitate alternativelor
- Yes
- Forme farmaceutice afectate
- Solution for injection in pre-filled syringe
- Denumire comună internațională (DCI) sau denumire uzuală
- inotersen
Conținutul paginii
- Shortage information
- Key facts
- Key dates
- Related medicine information
- Related content
Informații despre penurie
Tegsedi will be unavailable in the EU as of the end of 2026.
Tegsedi is a medicine used to treat nerve damage caused by hereditary transthyretin amyloidosis (hATTR), a disease in which proteins called amyloids build up in tissues around the body including around the nerves.
It is used in adults in the first two stages of the nerve damage (stage 1, when the patient can walk unaided, and stage 2, when the patient can still walk but needs help).
Tegsedi contains the active substance inotersen.
For further information on the use of the medicine please refer to the medicine’s page.
The company marketing Tegsedi, Akcea Therapeutics Ireland Ltd., is permanently discontinuing the medicine for commercial reasons, in particular low use of the medicine due to the availability of other suitable treatments. The medicine will therefore be unavailable in the EU as of the end of 2026.
The discontinuation is not related to a quality defect of the product or a safety issue.
The discontinuation affects all Member States where the product is marketed: Austria, Bulgaria, France, Germany, Greece, Ireland, Italy, Luxembourg, Poland, Portugal, Spain and Sweden.
For up-to-date information about the status of a medicine shortage in a particular Member State, consult the national shortage register, where available, or contact the national competent authority.
EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) and EMA’s shortages working party (Medicines Shortages Single Point of Contact – SPOC - working party) are closely monitoring the supply situation and engaging with the marketing authorisation holder to mitigate the impact of the supply shortage.
The SPOC Working Party Supports EMA’s MSSG and monitors and reports events that could affect the supply of medicines in the EU.
- Do not start new patients on Tegsedi.
- Transition all patients who are currently taking Tegsedi to an appropriate treatment alternative for stage 1 or stage 2 polyneuropathy due to hATTR.
- A medicine shortage communication (MSC) will be sent to healthcare professionals in affected Member States and will also be published on the EMA website.
- For additional information consult your country’s shortage register, where available, or contact your national competent authority.
- You may also contact relevant healthcare professional organisations for further information. A list of European not-for-profit organisations EMA engages with can be found on the EMA website.
- If you are taking Tegsedi, your doctor will switch you to a suitable treatment alternative.
- If you were due to start treatment with this medicine, your doctor will prescribe you a suitable alternative.
- If you have any questions, speak to your doctor or pharmacist.
- For additional information, consult your country’s shortage register, where available, or contact your national competent authority.
- You may also contact relevant patients’ organisations for further information or support. A list of European not-for-profit organisations that EMA engages with can be found on the EMA website.
Motivul penuriei
The company marketing Tegsedi, Akcea Therapeutics Ireland Ltd., is permanently discontinuing the medicine for commercial reasons, in particular low use of the medicine due to the availability of other suitable treatments. The medicine will therefore be unavailable in the EU as of the end of 2026.
The discontinuation is not related to a quality defect of the product or a safety issue.
State membre afectate
The discontinuation affects all Member States where the product is marketed: Austria, Bulgaria, France, Germany, Greece, Ireland, Italy, Luxembourg, Poland, Portugal, Spain and Sweden.
For up-to-date information about the status of a medicine shortage in a particular Member State, consult the national shortage register, where available, or contact the national competent authority.
Monitorizarea deficitului
EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) and EMA’s shortages working party (Medicines Shortages Single Point of Contact – SPOC - working party) are closely monitoring the supply situation and engaging with the marketing authorisation holder to mitigate the impact of the supply shortage.
The SPOC Working Party Supports EMA’s MSSG and monitors and reports events that could affect the supply of medicines in the EU.
Recomandări pentru profesioniștii din domeniul sănătății
- Do not start new patients on Tegsedi.
- Transition all patients who are currently taking Tegsedi to an appropriate treatment alternative for stage 1 or stage 2 polyneuropathy due to hATTR.
- A medicine shortage communication (MSC) will be sent to healthcare professionals in affected Member States and will also be published on the EMA website.
- For additional information consult your country’s shortage register, where available, or contact your national competent authority.
- You may also contact relevant healthcare professional organisations for further information. A list of European not-for-profit organisations EMA engages with can be found on the EMA website.
Recomandări pentru pacienți și îngrijitori
- If you are taking Tegsedi, your doctor will switch you to a suitable treatment alternative.
- If you were due to start treatment with this medicine, your doctor will prescribe you a suitable alternative.
- If you have any questions, speak to your doctor or pharmacist.
- For additional information, consult your country’s shortage register, where available, or contact your national competent authority.
- You may also contact relevant patients’ organisations for further information or support. A list of European not-for-profit organisations that EMA engages with can be found on the EMA website.
Informații cheie
- Medicines affected
- Tegsedi
- Supply shortage status
- Shortage ongoing
- International non-proprietary name (INN) or common name
- inotersen
- Pharmaceutical forms affected
- Solution for injection in pre-filled syringe
- Availability of alternatives
- Yes
Date cheie
- First published
Informații medicale conexe
🔬 Detalii medicale / tehnice pentru profesioniști
Toate informațiile de pe această pagină provin din comunicatul oficial al agenției. Noi le traducem și le sintetizăm; nu adăugăm și nu modificăm fapte.