SEVIKAR HCT 40/10/12.5 Olmesartan medoxomil 40 mg, amlodipine (as besilate) 10 mg and hydrochlorothiazide 12.5mg tablet blister pack, Merck Sharp Dohme (Australia) Pty Ltd, CON-623
Product name
SEVIKAR HCT 40/10/12.5 Olmesartan medoxomil 40 mg, amlodipine (as besilate) 10 mg and hydrochlorothiazide 12.5mg tablet blister pack
Sponsor name
Merck Sharp Dohme (Australia) Pty Ltd
Consent start
Consent no.
CON-623
Standard
Sections 9(3a) and 9(5) of the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The size and layout of the active ingredient and strength information does not
comply with TGO 91 and a commitment to lodge a variation request to address this
matter has been made.
Therapeutic product type
Prescription medicines