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KEYTRUDA (Merck Sharp & Dohme (Australia) Pty Ltd)
Product name
KEYTRUDA
Date registered
Evaluation commenced
Decision date
Approval time
136 working days (255)
Active ingredients
pembrolizumab
Registration type
EOI
Indication
KEYTRUDA (powder for injection) is now indicated as monotherapy for the adjuvant treatment of patients with melanoma with lymph node involvement who have undergone complete resection.
Registration process
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available