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Vyndaqel 61mg is indicated for the treatment of wild‑type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Refer to section 4.8 of the SmPC for how to report adverse reactions.
In the ATTR-ACT trial, the frequency of adverse events in patients treated with VYNDAQEL 80 mg* was generally similar and comparable to placebo1
In patients treated continuously with VYNDAQEL 80 mg to VYNDAQEL (tafamidis) 61 mg*, no new safety concerns were identified throughout the ATTR-ACT LTE study, and adverse events remained similar to placebo2
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Adverse events should be reported. Report an adverse event to your national reporting system (HPRA Pharmacovigilance)
Adverse events should also be reported to Pfizer Medical Information on 1800 633 363
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PP-UNP-IRL-0176. January 2023