The pharmaceuticals giant, Roche, has withdrawn a bid to win approval for sales in Europe of the influenza drug, Tamiflu. It said the body handling the bid had asked for more information, and that it would re-submit the application as soon as possible.
Roche said several members of the Committee for Proprietary Medicinal Products (CPMP) wanted more detail on one of two influenza viruses, known as Influenza B.
The Basel-based company said it expected to be able to provide the information and submit the bid again before the next wave of influenza in Europe.
Tamiflu is already available in nine countries, including Switzerland, the United States, Canada, and several in Latin America.
The drug has become one of Roche's best-selling products, being used in those markets to treat hundreds of thousands of patients during the last influenza season. Roche is pressing for Tamiflu to be authorised in the US for use as a preventive drug, as well as to treat symptoms.
swissinfo with agencies