Marketing Authorisation for the Antiretroviral Medicinal Product Viracept is Suspended

BRUSSELS, Aug. 7, 2007-Following the recall of the product from the EU market in June 2007, the European Commission has suspended the marketing authorisation for Roche’s antiretroviral medicinal product Viracept - an antiretroviral medicine used in combination with other antiviral medicines to treat adults, adolescents and children over 3 years of age who are infected with human immunodeficiency virus (HIV-1). The suspension follows the contamination of certain batches of Viracept with ethyl mesilate, a genotoxic substance. The decision is based on scientific conclusions of the European Medicines Agency (EMEA), and follows consultation with Member States. The suspension can only be lifted by a further decision of the Commission, after an assessment by the Agency of new data.

Background

Medicinal products can only be placed on the Community market after receiving a marketing authorisation based on an assessment of their quality, safety and efficacy. A marketing authorisation for Viracept was granted to Roche Registration Limited by the European Commission in 1998, following a scientific assessment by the European Medicines Agency (EMEA).

In early June 2007, the marketing authorisation holder informed the EMEA that it had found that certain batches of Viracept had been contaminated during the manufacturing process with ethyl mesilate (also known as methane sulfonic acid ethylester or ethylmethane sulfonate, EMS), a genotoxic substance. To ensure the immediate suspension of use of the product the marketing authorisation holder immediately recalled all packs of Viracept on the Community market and informed prescribing doctors about the incident. All packs of Viracept available on the market were recalled, including packs that patients may have had at home.

The European Commission asked the Committee for Medicinal Products for Human Use at the EMEA for its opinion on the quality and safety of Viracept in the light of the finding of contaminated batches.

The EMEA recommended, on 21 June 2007, the suspension of the marketing authorisation of Viracept, because of concerns that the quality of the product and therefore its safety in normal conditions of use can not be guaranteed at present. It further recommended that a toxicological study be carried out in order to calculate toxic levels of ethyl mesilate more precisely, as well as the establishment of a patient monitoring register which should include the patients who have been exposed to the contamination and all pregnant women and children who have ever been exposed to the product.
For more information, see the EMEA website:
http://www.emea.europa.eu/pdfs/general/direct/pr/27536707en.pdf

http://www.emea.europa.eu/humandocs/PDFs/EPAR/Viracept/27637907en.pdf

Posted: August 2007


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