VYNDAQEL 20 mg Soft capsule Ref.[9771] Active ingredients: Tafamidis

Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050, Bruxelles, Belgium

Product name and form

Vyndaqel 20 mg soft capsules.

Pharmaceutical Form
Soft capsule. Yellow, opaque, oblong (approximately 21 mm) capsule imprinted with “VYN 20” in red.

Qualitative and quantitative composition

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
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
Capsule shell: Gelatine (E441) Glycerine (E422) Yellow iron oxide (E172) Sorbitan Sorbitol (E420) Mannitol (E421) Titanium dioxide (E171) Purified water Capsule contents: Macrogol 400 (E1521) Sorbitan monooleate (E494) Polysorbate 80 (E433) Printing ink (Opacode purple): Ethyl alcohol Isopropyl alcohol Purified water Macrogol 400 (E1521) Polyvinyl acetate phthalate Propylene glycol (E1520) Carmine (E120) Brilliant Blue FCF (E133) Ammonium hydroxide (E527) 28%

Pack sizes and marketing

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.

Marketing authorization holder

Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050, Bruxelles, Belgium

Marketing authorization dates and numbers

EU/1/11/717/001
EU/1/11/717/002

Date of first authorisation: 16 November 2011
Date of latest renewal: 22 July 2016

Drugs

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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