2017-12 INN Report - European Medicines Agency - Europa EU
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28 November 2017 EMA/789956/2017 Information Management Division
Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use December 2017
This document lists information on applications for centralised marketing authorisation for human medicines that the European Medicines Agency has received for evaluation. 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 area. This 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 28 November 2017. Information 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). 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from this list once the medicine has received a positive or negative opinion from the CHMP or when the applicant has withdrawn the application. The Agency publishes information on these opinions and withdrawn applications on its website.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 highlights.
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Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use EMA/789956/2017
Page 2/5
International non-proprietary name
Therapeutic area
i
(salt, ester, derivative, etc.) / Common Name Ertugliflozin (L-pyroglutamic acid) / sitagliptin (phosphate monohydrate)
Medicines used in diabetes
Galcanezumab
Analgesics
Glycopyrronium / formoterol (fumarate dihydrate)
Medicines for obstructive airway diseases
Human herpesvirus 3
Vaccines
Influenza vaccine surface antigen inactivated prepared in cell cultures
Vaccines
Lesinurad / allopurinol
Antigout medicines
Macimorelin (acetate)
Diagnostic medicines
Melatonin
Psycholeptics
Meropenem (trihydrate) /vaborbactam,
Antibacterials for systemic use
Naldemedine (tosilate)
Medicines for constipation
Neratinib
Antineoplastic medicines
Peramivir
Antivirals for systemic use
Semaglutide
Medicines used in diabetes
Tildrakizumab
Immunosuppressants
i ii
Based on the ATC therapeutic sub-group. Application being reviewed under EMA’s accelerated assessment programme.
Non-orphan generic and biosimilar medicinal products International non-proprietary name /
Therapeutic area
i
Common Name
Total number of applications
Adalimumab
Immunosuppressants
3
Anagrelide
Antineoplastic medicines
1
Buprenorphine
1
Carmustine
Other nervous system medicines Antineoplastic medicines
Deferiprone
Other therapeutic medicines
1
Doxorubicin
Antineoplastic medicines
1
Efavirenz / emtricitabine / tenofovir
Antivirals for systemic use
1
Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use EMA/789956/2017
1
Page 3/5
International non-proprietary name /
Therapeutic area
i
Common Name
Total number of applications
disoproxil Gefitinib
Antineoplastic medicines
1
Hydrocortisone
1
Infliximab
Corticosteroids for systemic use Immunosuppressants
Insulin glargine
Medicines used in diabetes
1
Lenalidomide
Immunosuppressants
1
Nitisinone
1
Paclitaxel
Other alimentary tract and metabolism products Antineoplastic medicines
Pegfilgrastim
Immunostimulants
6
Pemetrexed
Antineoplastic medicines
1
Prasugrel
Antithrombotic medicines
1
Rotigotine
Anti-parkinson medicines
1
Sufentanil
Anesthetics
1
Trastuzumab
Antineoplastic medicines
4
Vigabatrin
Antiepileptics
1
i
1
1
Based on the ATC therapeutic sub-group.
Orphan medicinal products
International non-proprietary name (salt, ester,
Therapeutic area
i
derivative, etc.) / Common Name Axicabtagene ciloleucel
Antineoplastic medicines
ii
Burosumab
Medicines for bone diseases
Caplacizumab
Antithrombotic medicines
Damoctocog alfa pegol
Antihemorrhagics
Daunorubicin (hydrochloride)/ cytarabine
ii
Antineoplastic medicines
Entolimod
Immunostimulants
Eteplirsen
Other medicines for disorders of the musculo-skeletal system Immunosuppressants
Expanded human allogeneic mesenchymal adult stem cells extracted from adipose tissue
Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use EMA/789956/2017
Page 4/5
International non-proprietary name (salt, ester,
Therapeutic area
i
derivative, etc.) / Common Name Gemtuzumab ozogamicin
Antineoplastic medicines
Glibenclamide
Medicines used in diabetes
Inotersen (sodium)
ii
Other nervous system medicines
Masitinib (mesylate)
Antineoplastic medicines
Metreleptin
Mogamulizumab
Other alimentary tract and metabolism products Other medicines for disorders of the musculo-skeletal system Antineoplastic medicines
Paclitaxel
Antineoplastic medicines
Pacritinib (citrate)
Antineoplastic medicines
Plitidepsin
Antineoplastic medicines
Ropeginterferon alfa-2b
Immunostimulants
Rucaparib (camsylate)
Antineoplastic medicines
Sodium benzoate Tezacaftor / ivacaftor
Other alimentary tract and metabolism products Other respiratory system medicines
Tisagenlecleucel
Antineoplastic medicines
Mexiletine hcl
ii
Velmanase alfa
Volanesorsen (sodium)
Other alimentary tract and metabolism products Other alimentary tract and metabolism products Antineoplastic and immunomodulating agents Lipid modifying medicines
Vonicog alfa
Antihemorrhagics
Voretigene neparvovec
Ophthalmologicals
Vestronidase alfa Viable T-cells
i ii
Based on the ATC therapeutic sub-group. Application being reviewed under EMA’s accelerated assessment programme.
Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use EMA/789956/2017
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