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AusPAR: Nintedanib (as esilate)
Related information
Australian Public Assessment Report
17 March 2021
| AusPAR | |
|---|---|
| Active Ingredient | Nintedanib (as esilate)
|
| Product Name | Ofev/Vargatef
|
| Sponsor | Boehringer Ingelheim Pty Limited
|
| 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
|
| AusPAR Date | 26 February 2021
|
| Publication Date | 17 March 2021 |