Tafamidis Accord

Opinion

EMA has issued an opinion on this medicine

tafamidis

Overview

On 23 July 2026 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the granting of a marketing authorisation for the medicinal product Tafamidis Accord, intended for the treatment of hereditary transthyretin amyloidosis in adult patients with cardiomyopathy.

The applicant for this medicinal product is Accord Healthcare S.L.U.

Tafamidis Accord will be available as 61 mg capsules. The active substance of Tafamidis Accord is tafamidis (ATC code: N07XX08), a selective stabilizer of transthyretin tetramer.

Tafamidis Accord is a generic of Vyndaqel, which has been authorised in the EU since 16 November 2011. Studies have demonstrated the satisfactory quality of Tafamidis Accord, and its bioequivalence to the reference product Vyndaqel.

The full indication is:

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

Tafamidis Accord should be initiated under the supervision of a physician knowledgeable in the management of patients with amyloidosis or cardiomyopathy. 

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.

CHMP summary of positive opinion for Tafamidis Accord

Adopted Reference Number: EMADOC-1829012207-57965

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
• 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 applicant:
  Accord Healthcare S.L.U.
• Opinion adopted:
  23/07/2026
• Opinion status:
  Positive