1887-8571 1887-8571 S1887-85712020000100004 10.4321/s1887-85712020000100004 España España España España 00 03 2020 00 03 2020 76 1 19 24

1 AEMPS 2019 2 2020 127 72-84 3 EMA 4 AEMPS 2019 5 EMA 2019 6 2018 67 657-66 7 EMA 8 2019 22 10 10 616-30 9 2018 75 2 2 139-48 10 2019 176 6 6 428-38 11 2018 175 620-30 12 2019 322 4 4 296 13 Janssen Research & Development LLC 14 AEMPS 2019 15 2019 94 546-53 16 2018 93 921-30 17 18 2018 19 1007-13 19 2018 20 1316-20 20 21 FDA 22 EMA 23 EMA 24 25 2019 104 8 8 3437-49 26 2016 19 2 2 138-48 27 ClinicalTrials.gov 28 ClinicalTrials.gov 29 2015 16 6 6 704-15 30 2019 6 5 5 e254-65 31 EMA 32 EMA 33 EMA 34 2018 33 1219-26 35 EMA 36 2018 391 10127 10127 1263-73 37 2018 8 8 8 38 EMA 39 2019 85 359-70 40 2018 391 10139 10139 2513-24 41 2018 391 10139 10139 2503-12 42 2019 393 10188 10188 2303-11 43 2019 71 11 11 1788-800 44 EMA 45 2019 46 2017 215 12 12 1789-98