Comparable overseas reports pathway - first registration decision

TGA

2 November 2018 - Cabozantinib (Cabometyx) is the first medicine to be registered on the Australian Register of Therapeutic Goods via the TGA's new comparable overseas reports pathway, which came into effect in January 2018.

The application relates to an extension of the available indications to include first line treatment of adults with poor or intermediate risk of advanced renal cell carcinoma. 

The extension of indication was registered on the Australian Register of Therapeutic Goods on 1 November 2018 following approval by EMA on 8 May 2018.

Read TGA news

Michael Wonder

Posted by:

Michael Wonder