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Home Industry News Roche receives recommendation for Viracept re-instatement

Roche receives recommendation for Viracept re-instatement

21st September 2007

The European Medicines Agency’s (EMEA) Committee for Human Medicinal Products (CHMP) has recommended that Roche’s HIV drug, Viracept has its marketing authorisation reinstated following its suspension earlier this year.

The Committee stated its satisfaction with the actions taken by Roche and the company will hope that this will serve as a green light for its overall re-instatement when the EU commission makes its final decision later this year.

William M. Burns, chief executive officer of Roche’s pharmaceutical division, defended the “responsible” action of the company after the drug was recalled following the discovery that some of the drug batches contained the substance called ethyl mesylate (EMS).

“We have worked tirelessly with the health authorities, physicians, health care providers, NGO treatment providers and, of course, patient groups on the recall.”

Mr Burns went on to stress that Roche fully intended to re-supply the HIV drug once the suspension was lifted but that a small delay in its availability may occur to patients.

Earlier this year, the Swiss drug maker Roche announced an agreement with the (EMEA) that would see it establish registries to monitor patients that have been exposed to chemical impurity.

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