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March 18, 2014
17:30 EDTTHRXTheravance says EC lifts suspension of Marketing Authorization for VIBATIV
In a regulatory filing, Theravance said on March 17, Theravance was informed by its partner, Clinigen Group that it had received a notification dated March 13 from the European Commission, EC, that the EC has lifted the Europe-wide suspension of Marketing Authorization and amended the Marketing Authorization for VIBATIV, telavancin, for the treatment of adults with nosocomial pneumonia, including ventilator-associated pneumonia, known or suspected to be caused by methicillin resistant Staphylococcus aureus, MRSA, when other alternatives are not suitable. Theravance and Clinigen have an exclusive commercialization agreement in the European Union and certain other European countries for VIBATIV.
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