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(CHMP) Agenda for the Meeting on 14-17 September 2020 14 September 2020 EMA/CHMP/481238/2020 Human Medicines Division Committee for medicinal products for human use (CHMP) Agenda for the meeting on 14-17 September 2020 Chair: Harald Enzmann – Vice-Chair: Bruno Sepodes 14 September 2020, 08:30 – 19:30, room 1C/ virtual meeting 15 September 2020, 08:30 – 19:30, room 1C/ virtual meeting 16 September 2020, 08:30 – 19:30, room 1C/ virtual meeting 17 September 2020, 08:30 – 18:00, room 1C/ virtual meeting Disclaimers Some of the information contained in this agenda is considered commercially confidential or sensitive and therefore not disclosed. With regard to intended therapeutic indications or procedure scopes listed against products, it must be noted that these may not reflect the full wording proposed by applicants and may also vary during the course of the review. Additional details on some of these procedures will be published in the CHMP meeting highlights once the procedures are finalised and start of referrals will also be available. Of note, this agenda is a working document primarily designed for CHMP members and the work the Committee undertakes. Note on access to documents Some documents mentioned in the agenda cannot be released at present following a request for access to documents within the framework of Regulation (EC) No 1049/2001 as they are subject to on- going procedures for which a final decision has not yet been adopted. They will become public when adopted or considered public according to the principles stated in the Agency policy on access to documents (EMA/127362/2006). Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union © European Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged. Table of contents 1. Introduction 9 1.1. Welcome and declarations of interest of members, alternates and experts ............ 9 1.2. Adoption of agenda ................................................................................................ 9 1.3. Adoption of the minutes ......................................................................................... 9 2. Oral Explanations 9 2.1. Pre-authorisation procedure oral explanations ....................................................... 9 2.1.1. fenfluramine - Orphan - EMEA/H/C/003933 .................................................................. 9 2.1.2. arachis hypogaea allergens / arachis hypogaea allergens - EMEA/H/C/004917 .................. 9 2.1.3. ivosidenib - Orphan - EMEA/H/C/005056 .................................................................... 10 2.2. Re-examination procedure oral explanations ....................................................... 10 2.3. Post-authorisation procedure oral explanations ................................................... 10 2.3.1. Lynparza - olaparib - EMEA/H/C/003726/II/0035 ......................................................... 10 2.3.2. Lynparza - olaparib - EMEA/H/C/003726/II/0036 ......................................................... 10 2.4. Referral procedure oral explanations ................................................................... 11 2.4.1. Ranitidine - EMEA/H/A-31/1491 ................................................................................ 11 3. Initial applications 11 3.1. Initial applications; Opinions ................................................................................ 11 3.1.1. bupivacaine - EMEA/H/C/004586 ............................................................................... 11 3.1.2. meningococcal group A, C, W135 and Y conjugate vaccine - Article 28 - EMEA/H/C/00508412 3.1.3. pegfilgrastim - EMEA/H/C/005085 ............................................................................. 12 3.1.4. obiltoxaximab - Orphan - EMEA/H/C/005169............................................................... 12 3.1.5. melphalan - EMEA/H/C/005173 ................................................................................. 12 3.1.6. rivaroxaban - EMEA/H/C/005279 ............................................................................... 13 3.1.7. influenza quadrivalent vaccine (rDNA) - EMEA/H/C/005159 .......................................... 13 3.2. Initial applications; List of outstanding issues (Day 180; Day 120 for procedures with accelerated assessment timetable) ...................................................................... 13 3.2.1. duvelisib - Orphan - EMEA/H/C/005381 ...................................................................... 13 3.2.2. autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti-CD19 CD28/CD3-zeta chimeric antigen receptor and cultured - Orphan - ATMP - EMEA/H/C/005102 ......................................... 13 3.2.3. lenalidomide - EMEA/H/C/005306 .............................................................................. 13 3.2.4. inclisiran - EMEA/H/C/005333 ................................................................................... 14 3.2.5. autologous CD34+ cell enriched population that contains hematopoietic stem and progenitor cells transduced ex vivo using a lentiviral vector encoding the human arylsulfatase A gene - Orphan - ATMP - EMEA/H/C/005321 .......................................................................... 14 3.2.6. glucagon - EMEA/H/C/005391 ................................................................................... 14 3.2.7. lumasiran - Orphan - EMEA/H/C/005040 .................................................................... 14 Committee for medicinal products for human use (CHMP) EMA/CHMP/481238/2020 Page 2/48 3.2.8. pemigatinib - Orphan - EMEA/H/C/005266 .................................................................. 14 3.2.9. netarsudil / latanoprost - EMEA/H/C/005107 ............................................................... 15 3.2.10. valoctocogene roxaparvovec - Orphan - ATMP - EMEA/H/C/004749 ............................... 15 3.2.11. rilpivirine - EMEA/H/C/005060 ................................................................................... 15 3.2.12. somapacitan - Orphan - EMEA/H/C/005030 ................................................................ 15 3.2.13. icosapent ethyl - EMEA/H/C/005398 .......................................................................... 16 3.2.14. cabotegravir - EMEA/H/C/004976 .............................................................................. 16 3.2.15. baloxavir marboxil - EMEA/H/C/004974 ...................................................................... 16 3.3. Initial applications; List of questions (Day 120; Day 90 for procedures with accelerated assessment timetable) ...................................................................... 16 3.3.1. idecabtagene vicleucel - Orphan - ATMP - EMEA/H/C/004662 ........................................ 16 3.3.2. tralokinumab - EMEA/H/C/005255 ............................................................................. 16 3.3.3. trastuzumab - EMEA/H/C/005124 .............................................................................. 17 3.3.4. roxadustat - EMEA/H/C/004871 ................................................................................. 17 3.3.5. pralsetinib - EMEA/H/C/005413 ................................................................................. 17 3.3.6. bevacizumab - EMEA/H/C/005433 ............................................................................. 17 3.3.7. azacitidine - EMEA/H/C/004761 ................................................................................. 17 3.3.8. sitagliptin - EMEA/H/C/005598 .................................................................................. 17 3.3.9. pegfilgrastim - EMEA/H/C/004780 ............................................................................. 18 3.3.10. sugammadex - EMEA/H/C/005403 ............................................................................. 18 3.3.11. tafasitamab - Orphan - EMEA/H/C/005436 .................................................................. 18 3.3.12. thiotepa - EMEA/H/C/005434 .................................................................................... 18 3.4. Update on on-going initial applications for Centralised procedure ........................ 18 3.4.1. leuprorelin - EMEA/H/C/005034 ................................................................................. 18 3.4.2. doxorubicin hydrochloride - EMEA/H/C/005330 ........................................................... 18 3.4.3. selumetinib - Orphan - EMEA/H/C/005244 .................................................................. 19 3.4.4. berotralstat - Orphan - EMEA/H/C/005138 .................................................................. 19 3.4.5. sodium thiosulfate - PUMA - EMEA/H/C/005130 ........................................................... 19 3.4.6. ponesimod - EMEA/H/C/005163 ................................................................................ 19 3.4.7. sildenafil - EMEA/H/C/005439 ................................................................................... 20 3.4.8. obeticholic acid - EMEA/H/C/005249 .......................................................................... 20 3.5. Re-examination of initial application procedures under Article 9(2) of Regulation no 726/2004 ............................................................................................................
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