CHMP Issues Opinions

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Meeting highlights from the Committee for Medicinal Products for Human Use () 18-21 November 2013

This page provides an overview of the adopted at the November 2013 meeting of the Committee for Medicinal Products for Human Use (CHMP) and other important outcomes.

Seven medicines recommended for approval

The CHMP recommended granting a marketing authorisation for Sovaldi (sofosbuvir) in combination with other medicines for the treatment of
chronic (long-term) hepatitis C in adults. Please see press release for
more information.

The CHMP recommended the approval of Tivicay in combination with other anti-retroviral medicines for the treatment
of adults and adolescents over 12 years of age infected with human
immunodeficiency virus (HIV). Please see press release for more
information.

The CHMP recommended marketing authorisations for two tuberculosis medicines. One is Deltyba (delamanid), which is recommended for the treatment of pulmonary
infections due to multidrug-resistant tuberculosis; the other is Para-aminosalicylic acid Lucane,
recommended for the treatment of multidrug-resistant tuberculosis. Both
are orphan medicines. Please see press release for more information.

The Committee also recommended the granting of a marketing authorisation for Xigduo for the treatment of type 2 diabetes.

The Committee gave a positive recommendation for Cholic Acid FGK for the treatment of inborn errors of primary bile acid synthesis. Cholic Acid FGK is an orphanRead more

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