Vyndaqel

tafamidis

Table of contents

Opinion

On 12 December 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Vyndaqel. The marketing authorisation holder for this medicinal product is Pfizer Europe MA EEIG.

The CHMP adopted a new indication for a new presentation Vyndaqel 61 mg soft capsules as follows:

"Vyndaqel is indicated for the treatment of wild‑type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM)."

For information, the full indications for Vyndaqel will be as follows:

For Vyndaqel 20 mg soft capsules:

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

For Vyndaqel 61 mg soft capsules:

"Vyndaqel is indicated for the treatment of wild‑type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM)."

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

Key facts

Name
Vyndaqel
Agency product number
EMEA/H/C/002294
International non-proprietary name (INN) or common name
  • tafamidis
Active substance
  • tafamidis
Therapeutic area
Amyloidosis
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.

Date opinion adopted
12/12/2019
Company name
Pfizer Europe MA EEIG
Status
Positive
Application type
Post-authorisation

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