SOTACOR sotalol hydrochloride 80 mg tablet blister pack, Arrow Pharma Pty Ltd , CON-224
Product name
SOTACOR sotalol hydrochloride 80 mg tablet blister pack
Sponsor name
Arrow Pharma Pty Ltd
Consent start
Consent no.
CON-224
Standard
Paragraph 8(1)(j) of the Therapeutic Goods Order No. 91 - Requirements for labels of prescription and related medicines
Non-compliance with standard
The product carton labels do not include a statement in relation to the
declarable substance sugars, as set out in Column 2 of Schedule 1 of TGO 91.
Therapeutic product type
Prescription medicines