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Table of contents
1. Introduction 8
1.1. Welcome and declarations of interest of members, alternates and experts ............ 8
1.2. Adoption of agenda ................................................................................................ 8
1.3. Adoption of the minutes ......................................................................................... 8
2. Oral Explanations 8
2.1. Pre-authorisation procedure oral explanations ....................................................... 8
2.2. Re-examination procedure oral explanations ......................................................... 8
2.3. Post-authorisation procedure oral explanations ..................................................... 8
2.4. Referral procedure oral explanations ..................................................................... 8
3. Initial applications 8
3.1. Initial applications; Opinions .................................................................................. 8
3.1.1. - alectinib - EMEA/H/C/004164 .................................................................................... 8
3.1.2. - chlormethine - Orphan - EMEA/H/C/002826 ................................................................ 9
3.1.3. - baricitinib - EMEA/H/C/004085 .................................................................................. 9
3.1.4. - pregabalin - EMEA/H/C/004277 ................................................................................. 9
3.1.5. - rituximab - EMEA/H/C/004112 .................................................................................. 9
3.1.6. simoctocog alfa - EMEA/H/C/004459 ............................................................................ 9
3.2. Initial applications; List of outstanding issues (Day 180; Day 120 for procedures with
accelerated assessment timetable) ...................................................................... 10
3.2.1. - abaloparatide - EMEA/H/C/004157 .......................................................................... 10
3.2.2. - rurioctocog alfa pegol - EMEA/H/C/004195 ............................................................... 10
3.2.3. - adalimumab - EMEA/H/C/004212 ............................................................................ 10
3.2.4. - fluciclovine (18F) - EMEA/H/C/004197 ..................................................................... 10
3.2.5. - ivabradine - EMEA/H/C/004241 ............................................................................... 11
3.2.6. - pemetrexed - EMEA/H/C/004488 ............................................................................. 11
3.2.7. - vosaroxin - Orphan - EMEA/H/C/004118 .................................................................. 11
3.2.8. - padeliporfin - EMEA/H/C/004182 ............................................................................. 11
3.2.9. - tofacitinib - EMEA/H/C/004214 ................................................................................ 11
3.2.10. - human IgG1 monoclonal antibody specific for human interleukin-1 alpha - EMEA/H/C/004388
............................................................................................................................. 11
3.2.11. - adalimumab - EMEA/H/C/004373 ............................................................................ 12
3.3. Initial applications; List of questions (Day 120; Day 90 for procedures with
accelerated assessment timetable) ...................................................................... 12
3.3.1. - cerliponase alfa - Orphan - EMEA/H/C/004065 .......................................................... 12
3.3.2. - efavirenz / emtricitabine / tenofovir disoproxil - EMEA/H/C/004240 ............................. 12
3.3.3. - levamisole - Orphan - EMEA/H/C/004330 ................................................................. 12
Committee for medicinal products for human use (CHMP)
EMA/847927/2016 Page 2/39