Planned maintenance may cause outages to the Department of Health and Aged Care’s network from 5:15 pm AEDT on 30 November to 10:00 pm AEDT on 1 December 2024. Access to TGA databases such as TBS Portal, ARTG and DAEN may be affected. We apologise for any inconvenience.
Elevit, Bayer Australia Ltd, CON-258
Product name
Elevit
Sponsor name
Bayer Australia Ltd
ARTG
Batches
CM 56061, CM56066, CM56062, CM56168, CM56169, CM56284
Consent start
Consent no.
CON-258
Standard
Subsection 11(b) of Therapeutic Goods Order No. 78 - Standard for Tablets and Capsules (TGO 78).
Non-compliance with standard
6 batches of the product do not comply with the current acceptance criteria for
average assay content of iodine (as potassium iodate) of 198-253 µg/tab (90.0%
to 115.0% of label claim).
Conditions imposed
The content of iodine must not be less than 90.0 percent and not more than
140.0 percent of the stated content on the label.
Therapeutic product type
Registered complementary medicines