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Published on 21 September 2007

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EMEA lifts suspension on Viracept


The EU’s drug regulator has recommended that an HIV drug which was suspended from the market should be allowed back on sale.

The EMEA’s Committee for Medicinal Products for Human Use (CHMP) believes Viracept® (nelfinavir) is now safe to use.

The drug is a protease inhibitor that can help control HIV by suppressing the virus and stopping it from making copies of itself.

But its licence was suspended on 6 August and the product was recalled after contamination during the manufacturing process with ethyl mesilate, which can harm DNA.

The CHMP has assessed the measures put in place by Viracept’s manufacturer, Roche, and these have been verified by an inspection of the manufacturing site.

The committee is now satisfied that the problem has been rectified, and has decided to recommend to the European Commission that the marketing authorisation suspension is lifted.

Once this decision has been issued, Roche will be able to resume supplying Viracept to patients.

Roche CEO William Burns said: “From the beginning of the recall, Roche acted responsibly, quickly and always in the best interests of patients.

“We have worked tirelessly with the health authorities, physicians, healthcare providers, NGO treatment providers and, of course, patient groups on the recall with the full intention of resupplying this medication.”

Copyright © PA Business 2007


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