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AusPAR: Nintedanib (as esilate)
Australian Public Assessment Report
Device/Product Name
Ofev/Vargatef
Active ingredients
Nintedanib (as esilate)
AusPAR Date
Published
Sponsor
Submission Number
PM-2019-04480-1-5
Submission Type
Extension of indications, variation to register entry resulting in a change of product information requiring evaluation of clinical, nonclinical, or bioequivalence data
Decision
Approved