Marketing Authorisation for the Antiretroviral Medicinal Product Viracept is Suspended
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
For more information, see the EMEA website:
Posted: August 2007