Applications for new human medicines under …

1 30 Churchill Place Canary Wharf London E14 5EU United KingdomTelephone+44 (0)20 3660 6000 Facsimile+44 (0)20 3660 5555 Send a question via our website agency of the European Union European medicines Agency, 2018. Reproduction is authorised provided the source is February 2018 EMA/72847/2018 Information Management DivisionApplications for new human medicines under evaluation by the Committee for medicinal Products for human UseFebruary 2018 This document lists information on Applications for centralised marketing authorisation for human medicines that the European medicines Agency has received for evaluation.

2 It includes the international non-proprietary names (INN) and therapeutic areas for all new innovative medicines under evaluation by the committee for medicinal products for human use (CHMP). For generic and biosimilar medicines , it includes the INN (active moiety only, with no information on salt, ester or derivative) and therapeutic list only includes information for medicines whose Applications have been validated at the time the report was compiled. The information in this report was compiled on 5 February on designated orphan medicines that are being assessed for marketing authorisation is also available in the monthly reports of the Committee for Orphan medicinal Products (COMP).

3 Information in bold corresponds to new entries in the monthly list. Entries are removed from this list once the medicine has received a positive or negative opinion from the CHMP or when the applicant has withdrawn the application. The Agency publishes information on these opinions and withdrawn Applications on its website. Information on CHMP opinions is also published in the monthly CHMP for new human medicines under evaluation by the committee for medicinal products for human use EMA/72847/2018 Page 2/5 Non-orphan medicinal productsInternational non-proprietary name (salt, ester, derivative, etc.)

4 / Common NameTherapeutic area iAbaloparatideCalcium homeostasisAbemaciclibAntineoplastic medicinesAndexanet alfaOther therapeutic medicinesBeclometasone (dipropionate anhydrous) / formoterol (fumarate dihydrate) / glycopyrronium (bromide) iiiMedicines for obstructive airway diseasesBetrixabanAntithrombotic medicinesBictegravir / emtricitabine / tenofovir alafenamide (fumarate)Antivirals for systemic useBinimetinibAntineoplastic medicinesBotulinum toxin type AMuscle relaxantsBrexpiprazolePsycholepticsBriga tinibAntineoplastic medicinesBuprenorphine (hydrochloride)Other nervous system medicinesCanakinumabImmunosuppressantsCi closporinOphthalmologicalsDengue tetravalent vaccine (live, attenuated)VaccinesDolutegravir (sodium) /rilpivirine (hydrochloride)Antivirals for systemic useDoravirineAntivirals for systemic useDoravirine / lamivudine / tenofovir disoproxil (fumarate)

5 Antivirals for systemic useDurvalumabAntineoplastic medicinesEncorafenibAntineoplastic medicinesEravacyclineAntibacterials for systemic useErenumabAnalgesicsFremanezumabAnalges icsGalcanezumabAnalgesicsGlycopyrronium / formoterol (fumarate dihydrate) medicines for obstructive airway diseasesInfluenza vaccine surface antigen inactivated prepared in cell culturesVaccinesLesinurad / allopurinolAntigout medicinesLorlatinibAntineoplastic medicinesApplications for new human medicines under evaluation by the committee for medicinal products for human use EMA/72847/2018 Page 3/5 International non-proprietary name (salt, ester, derivative, etc.)

6 / Common NameTherapeutic area iLusutrombopagAntihemorrhagicsMacimoreli n (acetate)Diagnostic medicinesMelatoninPsycholepticsMeropenem (trihydrate) /vaborbactam,Antibacterials for systemic useNaldemedine (tosilate) medicines for constipationNeratinibAntineoplastic medicinesPeramivirAntivirals for systemic useRomosozumabMedicines for bone diseasesTildrakizumabImmunosuppressantsZ anamivirAntivirals for systemic usei Based on the ATC therapeutic Submitted according to legal basis: Informed consent application (Article 10c of Directive No 2001/83/EC).Non-orphan generic and biosimilar medicinal productsInternational non-proprietary name / Common Name Therapeutic area iTotal number of applicationsAdalimumabImmunosuppressants 5 BuprenorphineOther nervous system medicines1 CarmustineAntineoplastic medicines1 DeferiproneOther therapeutic medicines1 DoxorubicinAntineoplastic medicines1 GefitinibAntineoplastic medicines1 InfliximabImmunosuppressants1 LenalidomideImmunosuppressants1 NitisinoneOther alimentary tract and metabolism products1 PaclitaxelAntineoplastic medicines1 PegfilgrastimImmunostimulants6

7 PemetrexedAntineoplastic medicines1 PrasugrelAntithrombotic medicines1 Applications for new human medicines under evaluation by the committee for medicinal products for human use EMA/72847/2018 Page 4/5 International non-proprietary name / Common Name Therapeutic area iTotal number of applicationsSufentanilAnesthetics1 TrastuzumabAntineoplastic medicines3 VigabatrinAntiepileptics1i Based on the ATC therapeutic sub-group. Orphan medicinal productsInternational non-proprietary name (salt, ester, derivative, etc.) / Common NameTherapeutic area iAsparaginaseAntineoplastic medicinesAvacopanImmunosuppressantsAxica btagene ciloleucel iiAntineoplastic medicinesCannabidiolAntiepilepticsCaplac izumabAntithrombotic medicinesDamoctocog alfa pegolAntihemorrhagicsDaunorubicin (hydrochloride)/ cytarabine iiAntineoplastic medicinesEntolimodImmunostimulantsEtepli rsenOther medicines for disorders of the musculo-skeletal systemGemtuzumab ozogamicinAntineoplastic medicinesGlibenclamideMedicines used in diabetesInotersen (sodium) iiOther nervous system medicinesMasitinib (mesylate)

8 Antineoplastic medicinesMetreleptinOther alimentary tract and metabolism productsMexiletine (hcl)Other medicines for disorders of the musculo-skeletal systemMogamulizumabAntineoplastic medicinesPaclitaxelAntineoplastic medicinesPacritinib (citrate)Antineoplastic medicinesPatisiran (sodium) iiOther nervous system medicinesRopeginterferon alfa-2bImmunostimulantsApplications for new human medicines under evaluation by the committee for medicinal products for human use EMA/72847/2018 Page 5/5 International non-proprietary name (salt, ester, derivative, etc.) / Common NameTherapeutic area iRucaparib (camsylate)Antineoplastic medicinesSodium benzoateOther alimentary tract and metabolism productsTezacaftor / ivacaftorOther respiratory system medicinesTisagenlecleucel iiAntineoplastic medicinesTreosulfanAntineoplastic medicinesVestronidase alfaOther alimentary tract and metabolism productsViable T-cellsAntineoplastic and immunomodulating agentsVolanesorsen (sodium)Lipid modifying medicinesVonicog alfaAntihemorrhagicsVoretigene neparvovecOphthalmologicalsi Based on the ATC therapeutic sub-group.

9 Ii Application being reviewed under EMA s accelerated assessment programme.