This is a summary of the European public assessment report (EPAR) for Vyndaqel. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Vyndaqel. This product originally had an [orphan designation for familial amyloid polyneuropathy](/en/medicines/human/orphan-designations/eu-3-06-401), granted on 28 August 2006. This designation was withdrawn from the Community register of orphan medicinal products in November 2021 at the end of the 10-year period of market exclusivity.
Therapeutic Indication
### Therapeutic indication Vyndaqel is indicated for the treatment of transthyretin amyloidosis in adult patients with stage-1 symptomatic polyneuropathy to delay peripheral neurologic impairment.
Therapeutic Area (MeSH)
ATC Code
N07XX08
ATC Item
tafamidis
Pharmacotherapeutic Group
Other nervous system drugs
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| tafamidis | N/A | 氯苯唑酸葡胺 |
EMA Name
Vyndaqel
Medicine Name
Vyndaqel
Aliases
N/A