Supply of the product Elevit with Iodine film-coated tablet

COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

Section 14 and 14A Notice

On 23 May 2014, the delegate of the Secretary of the Department of Health for the purposes of subsection 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”) gave consent to the importation and supply of Elevit with Iodine film-coated tablet AUST R 174543 that does not conform with the requirements of the sections 11(b) and 11 (c) of the Therapeutic Goods Order No. 78 Standard for Tablets and Capsules (TGO 78).

The consent applies to batches listed below but only until 31 July 2014. 

List 1- Batch numbers (total 3) 30 tablet packs

List 2 – Batch numbers (total 23) 100 tablet packs

The delegate of the Secretary has, under subsection 15(1) of the Act, made the consent subject to the following conditions:

1. that the content of the 18 active ingredients in Elevit with Iodine film-coated tablet AUST R 174543 complies with the limits stated table below (table 1)

Table 1