4 January 2018 EMA/3179/2018 Information Management Division
Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use January 2018
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 3 January 2018. 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from this list once the medicine has received a positive or negative opinion from the CHMP or when the applicant has withdrawn the application. The Agency publishes information on these opinions and withdrawn applications on its website.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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Based on the ATC therapeutic sub-group. Application being reviewed under EMA’s accelerated assessment programme. iii Submitted according to legal basis: Informed consent application (Article 10c of Directive No 2001/83/EC). i
ii
Non-orphan generic and biosimilar medicinal products International non-proprietary name /
Therapeutic area
i
Common Name
Total number of applications
Adalimumab
Immunosuppressants
5
Buprenorphine
1
Carmustine
Other nervous system medicines Antineoplastic medicines
Deferiprone
Other therapeutic medicines
1
Doxorubicin
Antineoplastic medicines
1
Gefitinib
Antineoplastic medicines
1
Infliximab
Immunosuppressants
1
Insulin glargine
Medicines used in diabetes
1
Lenalidomide
Immunosuppressants
1
Nitisinone
Other alimentary tract and metabolism products Antineoplastic medicines
1
Paclitaxel
Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use EMA/3179/2018
1
1
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International non-proprietary name /
Therapeutic area
i
Common Name
Total number of applications
Pegfilgrastim
Immunostimulants
6
Pemetrexed
Antineoplastic medicines
1
Prasugrel
Antithrombotic medicines
1
Rotigotine
Anti-parkinson medicines
1
Sufentanil
Anesthetics
1
Trastuzumab
Antineoplastic medicines
3
Vigabatrin
Antiepileptics
1
i
Based on the ATC therapeutic sub-group.
Orphan medicinal products
International non-proprietary name (salt, ester,
Therapeutic area
i
derivative, etc.) / Common Name Avacopan Axicabtagene ciloleucel
Immunosuppressants ii
Antineoplastic medicines
Caplacizumab
Antithrombotic medicines
Damoctocog alfa pegol
Antihemorrhagics
Daunorubicin (hydrochloride)/ cytarabine ii
Antineoplastic medicines
Entolimod
Immunostimulants
Eteplirsen Gemtuzumab ozogamicin
Other medicines for disorders of the musculo-skeletal system 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
Mexiletine (hcl)
Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use EMA/3179/2018
Page 4/5
International non-proprietary name (salt, ester,
Therapeutic area
i
derivative, etc.) / Common Name Ropeginterferon alfa-2b
Immunostimulants
Rucaparib (camsylate)
Antineoplastic medicines
Sodium benzoate Tezacaftor / ivacaftor
Other alimentary tract and metabolism products Other respiratory system medicines
Tisagenlecleucel ii
Antineoplastic medicines
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/3179/2018
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