Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use

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Cecilia Henry
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1 2 July 208 EMA/482350/208 Corr. Informaton Management Dvson Applcatons for new human under evaluaton by the Commttee for Medcnal Products for Human Use July 208 Ths document lsts nformaton on applcatons for centralsed marketng authorsaton for human that the European Medcnes Agency has receved for evaluaton. It ncludes the nternatonal non-propretary names (INN) and therapeutc areas for all new nnovatve under evaluaton by the Commttee for Medcnal Products for Human Use (CHMP). For generc and bosmlar, t ncludes the INN (actve moety only, wth no nformaton on salt, ester or dervatve) and therapeutc area. Ths lst only ncludes nformaton for whose applcatons have been valdated at the tme the report was compled. The nformaton n ths report was compled on 2 July 208. Informaton on desgnated orphan that are beng assessed for marketng authorsaton s also avalable n the monthly reports of the Commttee for Orphan Medcnal Products (COMP). Informaton n bold corresponds to new entres n the monthly lst. Entres are removed from ths lst once the medcne has receved a postve or negatve opnon from the CHMP or when the applcant has wthdrawn the applcaton. The Agency publshes nformaton on these opnons and wthdrawn applcatons on ts webste. Informaton on CHMP opnons s also publshed n the monthly CHMP hghlghts. 30 Churchll Place Canary Wharf London E4 5EU Unted Kngdom Telephone +44 (0) Facsmle +44 (0) Send a queston va our webste An agency of the European Unon European Medcnes Agency, 208. Reproducton s authorsed provded the source s acknowledged.

2 Non-orphan medcnal Internatonal non-propretary name (salt, ester, dervatve, etc.) / Common Name Abemacclb Andexanet alfa Angotensn II (acetate) Apalutamde Avatrombopag (maleate) Axalmogene flolsbac Bnmetnb Botulnum toxn type A Brgatnb Buprenorphne (hydrochlorde) Canaknumab Cemplmab Cprofloxacn Crsaborole Dacomtnb (monohydrate) Delafloxacn (meglumne) Dengue tetravalent vaccne (lve, attenuated) Doravrne Doravrne / lamvudne / tenofovr dsoproxl (fumarate) Durvalumab Edaravone Encorafenb Eravacyclne Fremanezumab Galcanezumab Glycopyrronum / formoterol (fumarate dhydrate) Influenza vaccne surface antgen nactvated prepared n cell cultures Other therapeutc Medcnes actng on the renn-angotensn system Endocrne therapy Muscle relaxants Other nervous system Other dermatologcal Vaccnes Other nervous system Analgescs Analgescs Medcnes for obstructve arway dseases Vaccnes Applcatons for new human under evaluaton by the Commttee for Medcnal Products for Human Use EMA/482350/208 Page 2/5

3 Internatonal non-propretary name (salt, ester, dervatve, etc.) / Common Name Levodopa L-lysne (hydrochlorde) / L-argnne (hydrochlorde) Lorlatnb Lusutrombopag Macmoreln (acetate) Melatonn Meropenem (trhydrate) /vaborbactam Naldemedne (toslate) Rsankzumab Romosozumab Sotaglflozn Talazoparb Tldrakzumab Zanamvr Ant-parknson Urologcals Dagnostc Psycholeptcs Medcnes for constpaton Medcnes for bone dseases Medcnes used n dabetes Correcton: Angotensn II (acetate) applcaton was frst recorded as beng revewed under EMA s accelerated assessment programme, whch s not the case. Non-orphan generc and bosmlar medcnal Internatonal non-propretary name / Common Name Total number of applcatons Adalmumab 2 Ambrsentan Anthypertensves 2 Atazanavr Bevaczumab Buprenorphne Cabaztaxel Deferprone Doxorubcn Antvrals for systemc use Other nervous system Other therapeutc Applcatons for new human under evaluaton by the Commttee for Medcnal Products for Human Use EMA/482350/208 Page 3/5

4 Internatonal non-propretary name / Common Name Total number of applcatons Etanercept Febuxostat Antgout Geftnb Hydroxycarbamde Ioflupane (23I) Dagnostc radopharmaceutcals Lenaldomde Mglustat Other almentary tract and metabolsm Pacltaxel Pegflgrastm Immunostmulants 8 Posaconazole Antmycotcs for systemc use Rtuxmab Slodosn Urologcals Trastuzumab Vgabatrn Antepleptcs Orphan medcnal Internatonal non-propretary name (salt, ester, dervatve, etc.) / Common Name Asparagnase Avacopan Cannabdol Damoctocog alfa pegol Enasdenb (mesylate) Entolmod Glutamne Lanadelumab Antepleptcs Immunostmulants Other hematologcal Applcatons for new human under evaluaton by the Commttee for Medcnal Products for Human Use EMA/482350/208 Page 4/5

5 Internatonal non-propretary name (salt, ester, dervatve, etc.) / Common Name Mexletne (hcl) Mogamulzumab Pacltaxel Pacrtnb (ctrate) Patsran (sodum) Pegvalase Ropegnterferon alfa-2b Tezacaftor / vacaftor Treosulfan Treprostnl Trentne (dhydrochlorde) Turoctocog alfa pegol Vable T-cells Volanesorsen (sodum) Voretgene neparvovec Other for dsorders of the musculo-skeletal system Other nervous system Immunostmulants Other respratory system Antthrombotc and mmunomodulatng agents Lpd modfyng Ophthalmologcals Applcaton beng revewed under EMA s accelerated assessment programme. Applcatons for new human under evaluaton by the Commttee for Medcnal Products for Human Use EMA/482350/208 Page 5/5

Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use

Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use 5 February 208 EMA/72847/208 Informaton Management Dvson Applcatons for new human medcnes under evaluaton by the Commttee for Medcnal Products for Human Use February 208 Ths document lsts nformaton on