Vyndaqel
tafamidis
Table of contents
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.
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Vyndaqel : EPAR - Summary for the public (PDF/78.69 KB)
First published: 18/11/2011
Last updated: 02/08/2016 -
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Vyndaqel : EPAR - Risk-management-plan summary (PDF/99.91 KB)
First published: 21/02/2020
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 | |
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Marketing-authorisation holder |
Pfizer Europe MA EEIG
|
Revision |
18
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Date of issue of marketing authorisation valid throughout the European Union |
16/11/2011
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Contact address |
Product information
11/02/2021 Vyndaqel - EMEA/H/C/002294 - IA/0069
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.