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PIFELTRO (Merck Sharp & Dohme (Australia) Pty Ltd)
Product name
PIFELTRO
Date registered
Evaluation commenced
Decision date
Approval time
197 working days (255)
Active ingredients
doravirine
Registration type
EOI
Indication
PIFELTRO (film coated tablet) is now indicated, in combination with other antiretroviral medicinal products, for the treatment of HIV-1 infection in adult patients:
- with no prior antiretroviral treatment history, OR
- to replace the current antiretroviral regimen in those who are Virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to doravirine.