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TOLVAPTAN GH (Lupin Australia Pty Limited)
Product name
TOLVAPTAN GH
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
121 (255 working days)
Active ingredients
Tolvaptan
Registration type
New generic medicine
Indication
TOLVAPTAN GH is indicated to slow the progression of cyst development and renal insufficiency of autosomal dominant polycystic kidney disease (ADPKD) in adults with chronic kidney disease (CKD) stage 1 to 3 at initiation of treatment with evidence of rapidly progressing disease (see Section 5.1 Pharmacodynamic Properties).