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PIRFENIDONE SANDOZ (Sandoz Pty Ltd)
Product name
PIRFENIDONE SANDOZ
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
123 (255 working days)
Active ingredients
pirfenidone
Registration type
New generic medicine
Indication
PIRFENIDONE SANDOZ (tablet) is indicated for the treatment of idiopathic pulmonary fibrosis (IPF)
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine