APO-OLMESARTAN/AMLODIPINE/HCTZ, OLAMLO HCT, OLMAKAR HCT, OLMESARTAN/AMLODIPINE HCT INTAS (Accord Healthcare Pty Ltd)
Product name
APO-OLMESARTAN/AMLODIPINE/HCTZ, OLAMLO HCT, OLMAKAR HCT, OLMESARTAN/AMLODIPINE HCT INTAS
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
152 working days (255)
Active ingredients
amlodipine besilate; olmesartan medoxomil; hydrochlorothiazide
Registration type
New generic medicine
Indication
APO-OLMESARTAN/AMLODIPINE/HCTZ, OLAMLO HCT, OLMAKAR HCT, OLMESARTAN/AMLODIPINE HCT INTAS (film-coated tablets) are indicated for the treatment of hypertension, either as replacement for olmesartan medoxomil, amlodipine and hydrochlorothiazide being already taken as separate tablets or as add-on therapy where a patient's blood pressure is not controlled on a dual combination.
This fixed dose combination is not indicated for initial therapy.