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 EPAR was last updated on 23/11/2017

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 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

Publication details
Marketing-authorisation holder
Pfizer Ltd
Revision
12
Date of issue of marketing authorisation valid throughout the European Union
16/11/2011
Contact address
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

Product information

12/10/2017 Vyndaqel - EMEA/H/C/002294 - II/0043

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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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