Tafamidis Accord（tafamidis）获欧盟上市许可：遗传性转甲状腺素蛋白淀粉样变性心肌病治疗仿制药

Application under evaluation
CHMP opinion
European Commission decision

Overview

Treatment with Tafamidis Accord should be started and supervised by a doctor knowledgeable in the management of patients with transthyretin amyloidosis or heart muscle disease. It is available as capsules to be taken by mouth once a day.

The medicine can only be obtained with a prescription. For more information about using Tafamidis Accord, see the package leaflet or contact your doctor or pharmacist.

In patients with transthyretin amyloidosis, a blood protein called transthyretin is defective and breaks easily. The broken protein forms a fibrous substance called amyloid that builds up in tissues and organs around the body, including the heart, where it interferes with their normal functions.

The active substance in Tafamidis Accord, tafamidis, is a transthyretin stabiliser. It attaches to transthyretin, which prevents the protein from breaking up, thereby stopping the formation of amyloid in the heart and slowing down the progression of heart disease.

Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Vyndaqel, and do not need to be repeated for Tafamidis Accord.

As for every medicine, the company provided studies on the quality of Tafamidis Accord. The company also carried out a study that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

Studies carried out with Tafamidis Accord are described in more detail in the medicine’s assessment reports.

Because Tafamidis Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

The European Medicines Agency concluded that, in accordance with EU requirements, Tafamidis Accord has been shown to have comparable quality and to be bioequivalent to the reference medicine. Therefore, the Agency’s view was that, as for Vyndaqel, the benefits of Tafamidis Accord outweigh the identified risks and it can be authorised for use in the EU.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tafamidis Accord have been included in the summary of product characteristics and the package leaflet. Any additional measures in place for Vyndaqel also apply to Tafamidis Accord where appropriate.

The company that markets Tafamidis Accord will provide educational material to all healthcare professionals expected to prescribe Tafamidis Accord. The material will include information about the need to use contraception (birth control) and avoid pregnancy while using the medicine. It also explains how to take part in a surveillance programme for pregnant women.

These materials may be made available by national competent authorities on their websites. A list of national repositories is available on this website.

As for all medicines, data on the use of Tafamidis Accord are continuously monitored. Suspected side effects reported with Tafamidis Accord are carefully evaluated and any necessary action taken to protect patients.

Tafamidis Accord received a marketing authorisation valid throughout the EU on 18 September 2026.

For information about the availability of this medicine in your country, contact your national competent authority.

Product information

Latest procedure affecting product information:N/0000384133

28/10/2026

icon globe

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

Product information documents contain:

summary of product characteristics (annex I);
manufacturing authorisation holder responsible for batch release (annex IIA);
conditions of the marketing authorisation (annex IIB);
labelling (annex IIIA);
package leaflet (annex IIIB).

Product details

Name of medicine

Tafamidis Accord

Active substance

tafamidis

International non-proprietary name (INN) or common name

tafamidis

Therapeutic area (MeSH)

Amyloidosis, Familial
Cardiomyopathies

Anatomical therapeutic chemical (ATC) code

N07XX08

Pharmacotherapeutic group

Other nervous system drugs

Therapeutic indication

Tafamidis Accord is indicated for the treatment of hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTRh-CM).

EMA product number

EMEA/H/C/006711

Generic

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Marketing authorisation holder

Accord Healthcare S.L.U.

Edificio Este Planta 6a
World Trade Center
Moll De Barcelona S/n
08039 Barcelona
SPAIN

Opinion adopted

23/07/2026

Marketing authorisation issued

18/09/2026

Revision

This page was last updated on 29/10/2026