Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Vyndaqel 61 mg soft capsules.
| Pharmaceutical Form |
|---|
|
Soft capsule. Reddish brown, opaque, oblong (approximately 21 mm) capsule printed with "VYN 61" in white. |
Each soft capsule contains 61 mg of micronized tafamidis.
Excipient with known effect:
Each soft capsule contains no more than 44 mg of sorbitol (E420).
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
Tafamidis is a selective stabiliser of transthyretin (TTR). Tafamidis binds to TTR at the thyroxine binding sites, stabilising the tetramer and slowing dissociation into monomers, the rate-limiting step in the pathogenesis of transthyretin amyloidosis. |
| List of Excipients |
|---|
|
Capsule shell: Gelatine (E441) Capsule contents: Macrogol 400 (E1521) Printing ink (Opacode white): Ethyl alcohol |
PVC/PA/alu/PVC-alu perforated unit dose blisters.
Pack sizes: a pack of 30 x 1 soft capsules and a multipack containing 90 (3 packs of 30 x 1) soft capsules.
Not all pack sizes may be marketed.
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
EU/1/11/717/003
EU/1/11/717/004
Date of first authorisation: 16 November 2011
Date of latest renewal: 22 July 2016
| Drug | Countries | |
|---|---|---|
| VYNDAQEL | Austria, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, Poland, Romania, Turkey, United Kingdom, United States |
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