AusPAR: Lumacaftor / ivacaftor
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Australian Public Assessment Report
21 September 2016
| AusPAR | |
|---|---|
| Active Ingredient | Lumacaftor / ivacaftor
|
| Product Name | Orkambi 200/125
|
| Sponsor | Vertex Pharmaceuticals Australia Pty Ltd
|
| Submission Number | PM-2015-00424-1-5
|
| Submission Type | New chemical entity in a fixed dose combination
|
| Decision | Approved
|
| AusPAR Date | 8 September 2016
|
| Publication Date | 21 September 2016 |