VYNDAQEL

This brand name is authorized in United States. It is also authorized in Austria, Brazil, Canada, Croatia, Cyprus, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, Poland, Romania, Spain, Turkey, UK.

Active ingredients

The drug VYNDAQEL contains one active pharmaceutical ingredient (API):

1	Tafamidis UNII ZU7CF08A1A - TAFAMIDIS MEGLUMINE
	Tafamidis is a selective stabiliser of transthyretin (TTR). Tafamidis binds to TTR at the thyroxine binding sites, stabilising the tetramer and slowing dissociation into monomers, the rate-limiting step in the pathogenesis of transthyretin amyloidosis.
	Read more about Tafamidis

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
VYNDAQEL 20 mg Soft capsule	MPI, EU: SmPC	European Medicines Agency (EU)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group		Classification
N07XX08	Tafamidis	N Nervous system → N07 Other nervous system drugs → N07X Other nervous system drugs → N07XX Other nervous system drugs
Discover more medicines within N07XX08

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
BR	Câmara de Regulação do Mercado de Medicamentos	522720030084717, 522720050085407
CA	Health Products and Food Branch	02495732
EE	Ravimiamet	1549751, 1684548, 1811630, 1811641
ES	Centro de información online de medicamentos de la AEMPS	11717001, 11717001IP
FI	Lääkealan turvallisuus- ja kehittämiskeskus	144490, 541372
FR	Base de données publique des médicaments	61420887, 66376626
GB	Medicines & Healthcare Products Regulatory Agency	221123, 385293
HK	Department of Health Drug Office	65208
IL	מִשְׂרַד הַבְּרִיאוּת	7750
IT	Agenzia del Farmaco	041663016, 041663028, 041663030
JP	医薬品医療機器総合機構	1290001M1022
LT	Valstybinė vaistų kontrolės tarnyba	1063738, 1076647, 1089462, 1089463
PL	Rejestru Produktów Leczniczych	100262375, 100433842
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W64784002, W64784003, W66576001
TR	İlaç ve Tıbbi Cihaz Kurumu	8681308191007
US	FDA, National Drug Code	0069-1975