Otsuka Submits Application to EMA
In late December 2013, Otsuka Pharmaceutical Co Ltd submitted an application to the European Medicines Agency (EMA) for marketing authorisation of tolvaptan for the treatment of ADPKD in Europe.
The EMA considers marketing application authorisations (MAA) at the monthly meeting of its Committee for Medicinal Products for Human Use (CHMP). It is understood that the process could take 6 months. We will let everyone know the outcome immediately.