Timetable: Initial (full) marketing authorisation …

1 European Medicines Agency, 2017. Reproduction is authorised provided the source is 1 / 13 EMA/119185/2015 Medicines Evaluation The timetables in this document may be subject to revisionInitial ( full ) marketing authorisation application assessment timetablesAssessment of Initial submission (120-day timetable)Assessment of responses to List of Questions (60-day timetable after clock-stop for submission of responses)Assessment of responses to List of Outstanding Issues (30-day timetable after clock-stop for responses)Assessment of responses to List of Outstanding Issues (30-day timetable after immediate responses)Assessment of Outstanding Issues following Oral Explanation (30-day timetable)31 October 201730 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website An agency of the European Union European Medicines Agency, 2017.

2 Reproduction is authorised provided the source is 2 / 13 Assessment of Initial submission (120-day timetable)Deadline for Submission (*)Start date (^)CHMP (Co) Rapporteur ARsPRAC Rapporteur ARComments from PRAC (**)Comments from CHMP (**)Early draft LOQ (for Peer review tele-conference) (#)PRAC outcome (~)Updated PRAC Rapporteur ARPeer review telecon-ference (TC)Draft LoQ List of Questions (LoQ) or OpinionA102/01/201719/01/201708/04/20172 1/04/201728/04/201728/04/201705/05/20170 5/05/201705/05/201708/05/201711/05/20171 8/05/2017A206/02/201723/02/201713/05/201 729/05/201702/06/201702/06/201709/06/201 709/06/201709/06/201712/06/201715/06/201 722/06/2017A306/03/201723/03/201710/06/2 01723/06/201730/06/201730/06/201706/07/2 01706/07/201706/07/201710/07/201713/07/2 01720/07/2017A4A527/04/201718/05/201705/ 08/201718/08/201725/08/201725/08/201701/ 09/201701/09/201701/09/201704/09/201707/ 09/201714/09/2017A624/05/201715/06/20170 2/09/201715/09/201722/09/201722/09/20172 8/09/201728/09/201728/09/201702/10/20170 5/10/201712/10/2017A726/06/201713/07/201 730/09/201713/10/201720/10/201720/10/201 726/10/201726/10/201726/10/201730/10/201 703/11/201709/11/2017A831/07/201717/08/2 01704/11/201717/11/201724/11/201724/11/2 01730/11/201730/11/201730/11/201704/12/2 01707/12/201714/12/2017A911/09/201728/09 /201716/12/201703/01/201805/01/201805/01 /201811/01/201811/01/201811/01/201815/01 /201818/01/201825/01/2018A1009/10/201726 /10/201715/01/201826/01/201802/02/201802 /02/201808/02/201808/02/201808/02/201812 /02/201815/02/201822/02/2018A1106/11/201 723/11/201712/02/201826/02/201802/03/201 802/03/201808/03/201808/03/201808/03/201 812/03/201815/03/201822/03/2018A1227/11/ 201728/12/201719/03/201803/04/201806/04/ 201806/04/201812/04/201812/04/201812/04/ 201816/04/201819/04/201826/04/2018A1315/ 01/201801/02/201823/04/201807/05/201811/ 05/201811/05/201817/05/201817/05/201817/ 05/201822/05/201824/05/201831/05/2018A14 12/02/201801/03/201822/05/201804/06/2018 08/06/201808/06/201814/06/201814/06/2018 14/06/201818/06/201821/06/201828/06/2018 A1508/03/201829/03/201818/06/201802/07/2 01806/07/201806/07/201812/07/201812/07/2 01812/07/201816/07/201819/07/201826/07/2 018A16A1730/04/201824/05/201813/08/20182 8/08/201831/08/201831/08/201806/09/20180 6/09/201806/09/201810/09/201813/09/20182 0/09/2018A1804/06/201821/06/201810/09/20 1824/09/201828/09/201828/09/201804/10/20 1804/10/201804/10/201808/10/201811/10/20 1818/10/2018A1902/07/201819/07/201808/10 /201822/10/201826/10/201826/10/201831/10 /201831/10/201831/10/201805/11/201808/11 /201815/11/2018A2030/07/201816/08/201805 /11/201819/11/201823/11/201823/11/201829 /11/201829/11/201829/11/201803/12/201806 /12/201813/12/2018A2117/09/201804/10/201 820/12/201807/01/201911/01/201911/01/201 917/01/201917/01/201917/01/201921/01/201 924/01/201931/01/2019A2215/10/201801/11/ 201821/01/201904/02/201908/02/201908/02/ 201914/02/201914/02/201914/02/201918/02/ 201921/02/201928/02/2019A2312/11/201829/ 11/201818/02/201904/03/201908/03/201908/ 03/201914/03/201914/03/201914/03/201918/ 03/201921/03/201928/03/2019A2426/11/2018 28/12/201818/03/201901/04/201905/04/2019 05/04/201911/04/201911/04/201911/04/2019 15/04/201917/04/201926/04/2019A2514/01/2 01930/01/201923/04/201902/05/201910/05/2 01910/05/201916/05/201916/05/201916/05/2 01920/05/201923/05/201929/05/2019 European Medicines Agency, 2017.

3 Reproduction is authorised provided the source is 3 / 13 Deadline for Submission (*)Start date (^)CHMP (Co) Rapporteur ARsPRAC Rapporteur ARComments from PRAC (**)Comments from CHMP (**)Early draft LOQ (for Peer review tele-conference) (#)PRAC outcome (~)Updated PRAC Rapporteur ARPeer review telecon-ference (TC)Draft LoQ List of Questions (LoQ) or OpinionA2611/02/201928/02/201920/05/2019 03/06/201907/06/201907/06/201913/06/2019 14/06/201914/06/201917/06/201920/06/2019 27/06/2019A2711/03/201928/03/201917/06/2 01901/07/201905/07/201905/07/201911/07/2 01911/07/201911/07/201915/07/201918/07/2 01925/07/2019A28A2906/05/201923/05/20191 2/08/201927/08/201930/08/201930/08/20190 5/09/201905/09/201905/09/201909/09/20191 2/09/201919/09/2019A3003/06/201920/06/20 1909/09/201923/09/201927/09/201927/09/20 1903/10/201903/10/201903/10/201907/10/20 1910/10/201917/10/2019A3101/07/201918/07 /201907/10/201921/10/201925/10/201925/10 /201931/10/201931/10/201931/10/201904/11 /201907/11/201914/11/2019A3329/07/201915 /08/201904/11/201918/11/201922/11/201922 /11/201928/11/201928/11/201928/11/201902 /12/201905/12/201912/12/2019A3416/09/201 903/10/201919/12/201906/01/202010/01/202 010/01/202016/01/202016/01/202016/01/202 020/01/202023/01/202030/01/2020A3514/10/ 201931/10/201920/01/202003/02/202007/02/ 202007/02/202013/02/202013/02/202013/02/ 202017/02/202020/02/202027/02/2020A3611/ 11/201928/11/201917/02/202002/03/202006/ 03/202006/03/202012/03/202012/03/202012/ 03/202016/03/202019/03/202026/03/2020A37 25/11/201902/01/202023/03/202006/04/2020 08/04/202008/04/202016/04/202017/04/2020 17/04/202020/04/202023/04/202030/04/2020 A3813/01/202030/01/202020/04/202004/05/2 02008/05/202008/05/202014/05/202014/05/2 02014/05/202018/05/202020/05/202028/05/2 020A3910/02/202027/02/202018/05/202001/0 6/202005/06/202005/06/202011/06/202011/0 6/202011/06/202015/06/202018/06/202025/0 6/2020A4009/03/202026/03/202015/06/20202 9/06/202003/07/202003/07/202009/07/20200 9/07/202009/07/202013/07/202016/07/20202 3/07/2020A41A4204/05/202021/05/202010/08 /202024/08/202028/08/202028/08/202003/09 /202004/09/202004/09/202007/09/202010/09 /202017/09/2020A4301/06/202018/06/202007 /09/202021/09/202025/09/202025/09/202001 /10/202001/10/202001/10/202005/10/202008 /10/202015/10/2020A4529/06/202016/07/202 005/10/202019/10/202023/10/202023/10/202 029/10/202029/10/202029/10/202003/11/202 005/11/202012/11/2020A4627/07/202013/08/ 202003/11/202016/11/202020/11/202020/11/ 202026/11/202026/11/202026/11/202030/11/ 202003/12/202010/12/2020A4714/09/202001/ 10/202021/12/202004/01/202108/01/202108/ 01/202114/01/202114/01/202114/01/202118/ 01/202121/01/202128/01/2021A4812/10/2020 29/10/202018/01/202101/02/202105/02/2021 05/02/202111/02/202111/02/202111/02/2021 15/02/202118/02/202125/02/2021A4909/11/2 02026/11/202015/02/202101/03/202105/03/2 02105/03/202111/03/202111/03/202111/03/2 02115/03/202118/03/202125/03/2021A5023/1 1/202024/12/202015/03/202129/03/202131/0 3/202131/03/202108/04/202109/04/202109/0 4/202112/04/202115/04/202122/04/2021A510 4/01/202121/01/202112/04/202126/04/20213 0/04/202130/04/202106/05/202106/05/20210 6/05/202110/05/202112/05/202120/05/2021A 5208/02/202125/02/202117/05/202131/05/20 2104/06/202104/06/202110/06/202110/06/20 2110/06/202114/06/202117/06/202124/06/20 21A5308/03/202125/03/202114/06/202128/06 /202102/07/202102/07/202108/07/202108/07 /202108/07/202112/07/202115/07/202122/07 /2021A54 European Medicines Agency, 2017.

4 Reproduction is authorised provided the source is 4 / 13 Deadline for Submission (*)Start date (^)CHMP (Co) Rapporteur ARsPRAC Rapporteur ARComments from PRAC (**)Comments from CHMP (**)Early draft LOQ (for Peer review tele-conference) (#)PRAC outcome (~)Updated PRAC Rapporteur ARPeer review telecon-ference (TC)Draft LoQ List of Questions (LoQ) or OpinionA5530/04/202120/05/202109/08/2021 23/08/202127/08/202127/08/202102/09/2021 03/09/202103/09/202106/09/202109/09/2021 16/09/2021A5631/05/202117/06/202106/09/2 02120/09/202124/09/202124/09/202130/09/2 02130/09/202130/09/202104/10/202107/10/2 02114/10/2021A5728/06/202115/07/202104/1 0/202118/10/202122/10/202122/10/202127/1 0/202128/10/202128/10/202129/10/202104/