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Vibativ is granted marketing authorisation

European marketing authorisation has been granted for Vibativ, a once-daily injection to treat hospital acquired nosocomial pneumonia

Astellas Pharma Europe and Theravance have announced that the European Medicines Agency (EMA) has granted marketing authorisation for Vibativ (telavancin hydrochloride), used to treat hospital-acquired nosocomial pneumonia via a once-daily bactericidal injection.

The authorisation follows a positive opinion from the Committee for Human Medicinal Products (CHMP) and grants the treatment of adults in Europe with nosocomial pneumonia including ventilator-associated pneumonia, known or suspected to be caused by MRSA. It has been granted for when other alternatives are not suitable.

Vibativ is a once-daily injectable lipoglycopeptide antibacterial agent that has a dual mechanism of action against Gram-positive bacteria, including resistant pathogens such as methicillin-resistant Staphylococcus aureus (MRSA).

Vibativ provides an "effective hospital antibiotic option for patients with hospital-acquired pneumonia caused by MRSA" stated Ken Jones, president and CEO of Astellas Pharma Europe.

15th September 2011

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