Vyndaqel - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation

tafamidis

Opinion

On 25 June 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Vyndaqel. The marketing authorisation holder for this medicinal product is Pfizer Europe MA EEIG.

The CHMP adopted a new pharmaceutical form, 61 mg film-coated tablets, in addition to the already authorised 20 mg and 61 mg soft capsules.

The indication for the new film-coated tablets will be as follows:

Vyndaqel is indicated for the treatment of wild‑type transthyretin amyloidosis in adult patients with cardiomyopathy (ATTRwt-CM).

The indications for Vyndaqel 20 mg and 61mg soft capsules remain unchanged and are described in the summary of product characteristics (SmPC).

Detailed recommendations for the use of this product will be described in the updated SmPC, which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

CHMP post-authorisation summary of positive opinion for Vyndaqel (X-0000287968)

Adopted Reference Number: EMADOC-1700519818-3264389

Key facts

• Name of medicine:
  Vyndaqel
• EMA product number:
  EMEA/H/C/002294
• Active substance:
  tafamidis
• International non-proprietary name (INN) or common name:
  tafamidis
• Therapeutic area (MeSH):
  Amyloidosis
• Anatomical therapeutical chemical (ATC) code:
  N07XX08
• Additional monitoring:

  This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

• Exceptional circumstances:

  This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance.

• Orphan:

  This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

• Marketing authorisation holder:
  Pfizer Europe MA EEIG
• Date of opinion:
  25/06/2026
• Status:
  Positive