REVOLADE (Novartis Pharmaceuticals Australia Pty Ltd)
Product name
REVOLADE
Date registered
Evaluation commenced
Decision date
Approval time
87 working days (255)
Active ingredients
eltrombopag olamine
Registration type
EOI
Indication
REVOLADE (film-coated tablet and powder for oral suspension) is now also indicated for the treatment of adult and paediatric patients 2 years and older with severe aplastic anaemia (SAA) for use in combination with standard immunosuppressive therapy (first-line SAA).
Registration process
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available