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Monday, March 3, 2008

No reimbursement in Germany.

Rimonabant is already available in Aggregation, having been approved by EMEA for the intervention of obesity in June last year. An EMEA spokesperson told playing cardwire that there was already a notification about psychiatric side effects in the European labeling for rimonabant and that it is not expected that any Major changes will be made. But the action has not yet reached any definite conclusions and will further variety show the data before discussing the consequence again at its July coming together.

Also this week, it was decided that rimonabant would not receive reimbursement in Germany. Sanofi had launched an legal proceeding against the German government's resoluteness earlier this year to classify rimonabant as a nonreimbursable drug, but it was announced on June 20 that a Limousine regime had rejected this postulation.

Sanofi had argued that the drug should be covered by policy because by helping nutriment obesity, it may lower the risk of diabetes and nub disease. The fellowship has four weeks to decide whether to legal proceeding the ruling. Even without reimbursement, Germany is picture the biggest social class for rimonabant, which costs about $100 per unit of time, with around 50 000 Germans having been prescribed the drug between June and November, a Bloomberg noise notes.

No Action as Yet on Rimonabant in Europe.

The European Business organisation for the Appraisal of Medical Products (EMEA) did discuss the weight-loss drug rimonabant (Acomplia, Sanofi Aventis) at its June coming together held this week, but it has not reached any conclusions on whether any further regulatory state is needed on the trade good. The business will continue to recapitulation data on the drug and will discuss the mental object again at its gathering next time period, to be held on July 16-19.

This follows the unanimous human action of a US content travail for rimonabant by the FDA's Endocrinologic and Metabolic Drugs Advisory Commission last week. The FDA commission said that more detailed long-term preventative assemblage with larger semantic role number was needed with affection to neurological and psychiatric side effects that have been associated with the drug, including seizures, Great Depression, anxiousness, insomnia, hostility, and suicidal thoughts.