ADR that result in revision of patient information

China: Notice related to Pioglitazone label changes

In Hong Kong, there are 24 registered pharmaceitucal products containing pioglitazone and are prescription-only medicines. Related news has been released by the EMA, FDA, Health Canada, TGA, MHRA HSA and SFDA and was posted on the website of Drug Office in June, July, August, October and November 2011 and April 2012. A letter to inform healthcare professionals was issued on 16 June 2011 and 22 July 2011. The issue was discussed in the Registration Committee of the Pharmacy and Poisons Board on 6 September 2011. The Committee decided that the package insert of pioglitazone-containing products should be updated to include appropriate safety information.. The Department of Health will keep vigilance against any new safety information in relation to the drug.

Please refer to the following Chinese website for details: http://www.drugoffice.gov.hk/eps/news/../16995.html
Ends/ Friday, May 04, 2012
Issued at HKT 13:13

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