Vyndaqel (tafamidis)
OrphanExceptional circumstancesAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- tafamidis
- Company
- Pfizer Europe MA EEIG
- Status
- Authorised
- Therapeutic area
- Amyloidosis
- CHMP opinion
- Thu 21 Jul 2011
- EU approval
- Wed 16 Nov 2011
- Designations
- Orphan, Exceptional circumstances, Additional monitoring
- Application
- EMEA/H/C/002294
- ATC
- N07XX08
- Official record
- www.ema.europa.eu
Indication
Vyndaqel is indicated for the treatment of transthyretin amyloidosis in adult patients with stage-1 symptomatic polyneuropathy to delay peripheral neurologic impairment.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Tafamidis Accord Authorised · Accord Healthcare S.L.U.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.