MEKINIST (Novartis Pharmaceuticals Australia Pty Ltd)
Product name
MEKINIST
Date registered
Evaluation commenced
Decision date
Approval time
96 working days (255)
Active ingredients
trametinib as dimethyl sulfoxide
Registration type
EOI
Indication
MEKINIST is now also indicated for:
- Adjuvant treatment of melanoma
MEKINIST in combination with dabrafenib is indicated for the adjuvant treatment of patients with melanoma with a BRAF V600 mutation and involvement of the lymph node(s), following complete resection.
Registration process
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available