European Medicines Agency recommends approval of a new medicine for multidrug-resistant tuberculosis

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European Medicines Agency

Published: Dec. 21, 2013, 3:38 p.m.·
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CHMP has recommended granting a conditional marketing authorisation for Sirturo (bedaquiline).

European Medicines Agency recommends two new treatment options for tuberculosis

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European Medicines Agency

Published: Nov. 23, 2013, 8:31 p.m.·
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The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the authorisation of Deltyba (delamanid) and Para-aminosalicylic acid Lucane (para-aminosalicylic acid), two treatment options for use in combination with other medicines against multidrug-resistant tuberculosis.

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EMA: Response to TB CAB letter

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European Medicines Agency

Published: March 22, 2013, 7:24 p.m.·
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EMA’s response to TB CAB letter regarding the filing of the drugs delamanid and bedaquiline for market approval.

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EMA: Response to TB CAB letter

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European Medicines Agency

Published: July 8, 2012, 10:29 a.m.·
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EMA’s response to TB CAB letter regarding conducting drug-drug interaction studies for bedaquiline (TMC207) and delamanid (OPC6783).

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