1134-8046 1134-8046 S1134-80462019000100061 10.20986/resed.2017.3556/2016 Spain 00 02 2019 00 02 2019 26 1 61 62 2011 93 187-97 2017 18 42-53 2016 16 251 European Medicines Agency (EMA) 2016