Posted by Michael Wonder on 02 May 2016
April 2016 NCE registrations - TGA
2 May 2016 - The TGA registered two new chemical entities (medicines) and two new blood products in April 2016.
The new medicines are:
- Cobimetinib hemifumarate (Cotellic) - use in combination with vemurafenib for the treatment of patients with unresectable or metastatic melanoma with BRAF V600 mutation
- Avanafil (Spedra) - treatment of erectile dysfunction in adult males
The new blood products are:
- Octocog alfa (Kovalty) - treatment and prophylaxis of bleeding in patients of all ages with haemophilia A (congenital factor VIII deficiency)
- Susoctocog alfa (Obizur) - treatment of bleeding episodes in adults with acquired haemophilia A
For more details, go to: http://www.tga.gov.au/prescription-medicines-registration-new-chemical-entities-australia
Posted by:
Michael Wonder