THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On January 10 2013, the delegate of the Secretary of the Department of Health and Ageing for the purposes of subsection 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”) gave his consent to:
(a) the supply of the following products by Sandoz Pty Ltd, Pyrmont NSW (“the Company”):
- amoxycillin (as trihydrate) and clavulanic acid (as potassium) (CURAM DUO FORTE 875/125) 875 mg/125 mg tablet strip pack [Aust R 82829]
- amoxycillin (as trihydrate) and clavulanic acid (as potassium) (CURAM DUO 500/125) 500 mg/125 mg tablet strip pack [Aust R 82830]
That do not conform with paragraphs 3(2)(a) and 3(2)(b) of Therapeutic Goods Order 69 in that the names of the active ingredients on the carton labels are expressed differently to the approved names.
Pursuant to subsection 15(1) of the Act, the consent given by the delegate of the Secretary as described above is subject to the following conditions:
- This consent applies until June 30 2013.
- The carton labels to be used are identical to those provided in correspondence from the Company dated November 15 2012.
- No other changes have been made to the products:
- amoxycillin (as trihydrate) and clavulanic acid (as potassium) (CURAM DUO FORTE 875/125) 875 mg/125 mg tablet strip pack [Aust R 82829]
- amoxycillin (as trihydrate) and clavulanic acid (as potassium) (CURAM DUO FORTE 500/125) 500 mg/125 mg tablet strip pack [Aust R 82830]