Vyndaqel

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tafamidis

Authorised
This medicine is authorised for use in the European Union.

Overview

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, 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 This designation was withdrawn from the Community register of orphan medicinal products in November 2021 at the end of the 10-year period of market exclusivity.

This EPAR was last updated on 10/12/2021

Authorisation details

Product details
Name
Vyndaqel
Agency product number
EMEA/H/C/002294
Active substance
tafamidis
International non-proprietary name (INN) or common name
tafamidis
Therapeutic area (MeSH)
Amyloidosis
Anatomical therapeutic chemical (ATC) code
N07XX08
Additional monitoringAdditional 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 circumstancesExceptional 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.

OrphanOrphan

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.

Publication details
Marketing-authorisation holder
Pfizer Europe MA EEIG
Revision
21
Date of issue of marketing authorisation valid throughout the European Union
16/11/2011
Contact address

Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Product information

06/12/2021 Vyndaqel - EMEA/H/C/002294 - IAIN/0077/G

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Other nervous system drugs

Therapeutic indication

Vyndaqel is indicated for the treatment of transthyretin amyloidosis in adult patients with stage-1 symptomatic polyneuropathy to delay peripheral neurologic impairment.

Assessment history

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