EMEA recommends reinstating license for Roche’s nelfinavir

On 20 September 2007, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended the lifting of the suspension of the marketing authorisation for nelfinavir (Viracept, manufacutred by Roche) and the re-introduction of the medicine onto the market in the European Union.

The marketing authorisation for Viracept was suspended on 6 August 2007, following the contamination during the manufacturing process of several batches of the active substance with ethyl mesilate, a known genotoxic substance. See previous Treatment Alerts in the previous two issues of HIV Treatment Bulletin. [1, 2].

The CHMP has assessed the corrective and preventive measures put in place by Roche, and these have also been verified by an inspection of the manufacturing site. As a result, the CHMP has been reassured that the cause of the contamination has been eliminated and that future production of Viracept would meet the required quality standards. The CHMP therefore decided to recommend to the European Commission the lifting of the marketing authorisation suspension.

Once this decision has been issued – this is not expected before the end of October – Roche will be able to resume supply of Viracept to patients. It is likely to take several months for nelfinavir to become available again. Countires in most need will be prioritised for the first supply.

Source: EMEA press release.

Nelfinavir reinstatement – EMEA press release PDF


  1. Roche recalls nelfinavir (Viracept) due to chemical impurity. HTB June/July 2007.
  2. Update on nelfinavir recall. HTB August/September 2007

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