1134-8046 1134-8046 S1134-80462018000400195 10.20986/resed.2018.3697/2018 Spain 00 08 2018 00 08 2018 25 4 195 196 European Medicines Agency (EMA) 2017 2017 18 1 1 42-53 2017 33 10 10 921-31 2016 20 2 2 316-28 2017 17 1 1 80