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OFEV, VARGATEF (Boehringer Ingelheim Pty Ltd)
Product name
OFEV, VARGATEF
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
170 working days (255)
Active ingredients
nintedanib esilate
Registration type
EOI
Indication
OFEV, VARGATEF (soft capsules) are now also indicated for slowing the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD).
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.