The application, known as a type II variation, was submitted to European regulatory authorities in October 2007. This Committee for Medicinal Products for Human Use (CHMP) positive opinion will be forwarded to the European Commission (EC), which will amend the marketing authorisation for Viread in the 27 countries of the European Union to reflect the type II variation.
The EC generally issues an updated marketing authorization within a few months following a positive CHMP recommendation.