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EMEA suspension of fentanyl iontophoretic transdermal system

25th November 2008

The European Medicines Agency (EMEA) has recommended the suspension of the marketing authorisation of Ionsys (fentanyl iontophoretic transdermal system) because of a defect with the delivery system that could lead to patients being overdosed. All batches were recalled in the EU in September 2008 as a precautionary measure (see news item 2008-09-30), however the company has been unable to resolve the problems and prevent this defect occurring. The EMEA has therefore concluded that the benefits of Ionsys no longer outweigh its risks and has recommended the suspension of the marketing authorisation until the company can robustly demonstrate the quality of the product.

EMEA press release