LEIDEN, THE NETHERLANDS, May 19, 2014 – Janssen Biologics B.V. announced today that the company has withdrawn its application seeking a change to the Marketing Authorization for SIMPONI® (golimumab) to add a new pharmaceutical form of intravenous (I.V.) administration for the treatment of adults with moderately to severely active rheumatoid arthritis (RA). Janssen Biologics informed the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) of its decision following receipt of an assessment report that indicated additional clinical data were required to further evaluate the risk:benefit profile of the I.V. formulation.
Janssen Withdraws Application In European Union Seeking Approval Of Intravenously Administered Simponi® | Johnson & Johnson
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