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tafamidis

Vyndaqel · ATC code N07XX08

Brand names: Vyndaqel, Tafamidis Stada, Tafamidis Viatris, Tafamidis Zentiva, Tafamidis Al

Key facts
Active substance
tafamidis
ATC code
N07XX08
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Vyndaqel 20 mg soft capsules · Vyndaqel 61 mg soft capsules · Vyndaqel 61 mg film-coated tablets
Marketing authorisation holder
Pfizer Europe MA EEIG
Information as of
2026-10-27

Key facts

Tafamidis is a transthyretin stabiliser. It is used in adults with transthyretin amyloidosis with polyneuropathy (20 mg) or with cardiomyopathy (61 mg).

What it is used for

  • Vyndaqel 20 mg: transthyretin amyloidosis in adults with stage 1 symptomatic polyneuropathy, to delay peripheral neurologic impairment
  • Vyndaqel 61 mg: wild-type or hereditary transthyretin amyloidosis in adults with cardiomyopathy (ATTR-CM)

Dosing

  • ATTR polyneuropathy: tafamidis meglumine 20 mg once daily
  • ATTR cardiomyopathy: Vyndaqel 61 mg (tafamidis) once daily; corresponds to 80 mg tafamidis meglumine
  • Tafamidis and tafamidis meglumine are not interchangeable on a per mg basis
  • No adjustment in the elderly, renal impairment or mild to moderate hepatic impairment; caution in severe hepatic impairment
  • For ATTR-CM, confirm diagnosis and exclude AL amyloidosis before starting; swallow capsules whole

Contraindications

  • Hypersensitivity to the active substance or any excipient

Important warnings

  • Add to standard of care; discontinue in patients who undergo liver or organ transplantation
  • Increase in liver function tests and decrease in thyroxine may occur
  • BCRP substrates: exposure may increase, monitor for related adverse reactions
  • Contains sorbitol; contraception until 1 month after stopping

Side effects

  • Polyneuropathy (20 mg), very common: urinary tract infection, diarrhoea, upper abdominal pain
  • Cardiomyopathy (61 mg), common: diarrhoea, rash, pruritus
  • Generally mild or moderate

Interactions

  • Inhibits BCRP: exposure to substrates such as methotrexate, rosuvastatin, atorvastatin, apixaban, rivaroxaban, imatinib may increase; consider dose reduction of the substrate
  • Does not induce or inhibit CYP3A4

Pregnancy and breastfeeding

  • Not recommended in pregnancy or in women of childbearing potential not using contraception; contraception for one month after stopping
  • Should not be used during breast-feeding

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

Source: European Medicines Agency (EMA), product information

Austria

  • Tafamidis StadaStada Arzneimittel Gmbh · 1 register entry
  • Tafamidis ViatrisViatris Limited · 1 register entry
  • Tafamidis ZentivaZentiva, K.S. · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

  • Tafamidis AlAliud Pharma Gmbh · 1 register entry
  • Tafamidis ViatrisViatris Germany Gmbh · 1 register entry
  • Tafamidis ZentivaZentiva Pharma Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • VyndaqelPFİZER PFE İLAÇLARI A.Ş. · 2 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 9 more European countries
Belgium
Tafamidis Eg, Tafamidis Viatris
Denmark
Tafamidis Zentiva
France
Tafamidis Biogaran, Tafamidis Eg, Tafamidis Viatris, Tafamidis Zentiva, Tafamidis Zydus
Iceland
Tafamidis Accord, Vyndaqel
Liechtenstein
Tafamidis Accord, Vyndaqel
Norway
Tafamidis Accord, Tafamidis Stada Nordic, Tafamidis Viatris, Tafamidis Zentiva, Vyndaqel
Slovenia
Tafamidis Sumar
Spain
Tafamidis Stada, Tafamidis Viatris, Tafamidis Zentiva
Sweden
Tafamidis Stada Nordic, Tafamidis Viatris, Tafamidis Zentiva

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. European Medicines Agency. Vyndaqel – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/vyndaqel-epar-product-information_en.pdf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.