LIVTENCITY (Takeda Pharmaceuticals Australia Pty Ltd)
Product name
LIVTENCITY
Date registered
Evaluation commenced
Decision date
Approval time
155 (255 working days)
Active ingredients
maribavir
Registration type
NCE/NBE
Indication
LIVTENCITY (film coated tablet) is indicated for the treatment of adults with post-transplant cytomegalovirus (CMV) infection and disease resistant, refractory or intolerant to one or more prior therapies (see 4.3 CONTRAINDICATIONS and, 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE).
Registration process
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.