ADR that result in revision of patient information
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| Taiwan: Announcement on unification of contraindications and related matters regarding oral medicines containing flurbiprofen |
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In Hong Kong, there are 2 registered pharmaceutical products containing flurbiprofen, namely Strepfen Honey & Lemon Lozenge 8.75mg (HK-61431) (manufactured in the United Kingdom) and Strepfen Honey & Lemon Lozenge 8.75mg (HK-63536) (manufactured in Thailand). The products are registered by Reckitt Benckiser Hong Kong Ltd, and are prescription-only medicines. Among the warnings mentioned in the announcement made by the Taiwan authority, except the contraindication of severe liver failure, other information is already included in the package insert of Strepfen. The TGA has released a news on hepatotoxicity of NSAIDs (including flurbiprofen), and the news was posted on the Drug Office website on 12 June 2015. Letters to healthcare professionals were issued on the same day to draw their attention to the warning. So far, the Department of Health has not received any adverse drug reaction report on flurbiprofen. As previously reported, the matter will be discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board.
Please refer to the following Chinese website for details:
http://www.drugoffice.gov.hk/eps/news/../24882.html
Ends/ Friday, June 26, 2015
Issued at HKT 14:00
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