Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050, Bruxelles, Belgium
Vyndaqel 20 mg soft capsules.
Pharmaceutical Form |
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Soft capsule. Yellow, opaque, oblong (approximately 21 mm) capsule imprinted with “VYN 20” in red. |
Each soft capsule contains 20 mg of micronized tafamidis meglumine equivalent to 12.2 mg 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 | Description | |
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Tafamidis |
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 |
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Capsule shell: Gelatine (E441) Capsule contents: Macrogol 400 (E1521) Printing ink (Opacode purple): Ethyl alcohol |
PVC/PA/alu/PVC-alu/PET/Paper perforated unit dose blisters.
Pack sizes: a pack of 30 × 1 soft capsules and a multipack containing 90 (3 packs of 30 × 1) soft capsules.
Not all pack sizes may be marketed.
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050, Bruxelles, Belgium
EU/1/11/717/001
EU/1/11/717/002
Date of first authorisation: 16 November 2011
Date of latest renewal: 22 July 2016
Drug | Countries | |
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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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