VYNDAMAX (Pfizer Australia Pty Ltd)
Product name
VYNDAMAX
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
187 working days (255)
Active ingredients
tafamidis
Registration type
NCE/NBE
Indication
VYNDAMAX (soft capsules) is indicated for the treatment of adult patients with wild-type or hereditary transthyretin amyloid cardiomyopathy (ATTR-CM).
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.