PHARMACOR SACUBITRIL/VALSARTAN (Pharmacor Pty Ltd)
Product name
PHARMACOR SACUBITRIL/VALSARTAN
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
180 (255 working days)
Active ingredients
sacubitril, valsartan
Registration type
New generic medicine
Indication
Pharmacor Sacubitril Valsartan 24mg/26mg, 49mg/51mg and 97mg/103mg is indicated in adult patients for the treatment of chronic heart failure (NYHA Class II-IV) with reduced ejection fraction.
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine