2014-01 inn report

EMA/21080/2014Procedure Management & Business Support Division Applications for new human medicines under evaluationby the Committee for Medicinal Products for Human UseJanuary 2014 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 6 January 2014.
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from this list once the medicine has received a positive or negative opinion from the CHMP or when the applicant has withdrawn the application. The Agency publishes information on these opinions and withdrawn applications on its website.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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European Medicines Agency, 2014. Reproduction is authorised provided the source is acknowledged.
Non-orphan medicinal products
International non-proprietary name
(salt, ester, derivative, etc.) / Common
Name
Aclidinium bromide / formoterol (fumarate Medicines for obstructive airway diseases Apremilast
Immunosuppressants
Sex hormones and modulators of the genital system conjugatedBrinzolamide / brimonidine (tartrate) Canagliflozin / metformin (hydrochloride) Cangrelor
Antithrombotic medicines
Ciclosporin
Ophthalmologicals
Clopidogrel (bisulfate)/acetylsalicylic acid Daclatasvir (dihydrochloride)
Antivirals for systemic use
Dalbavancin (hydrochloride)
Antibacterials for systemic use
Human alpha1-proteinase inhibitor
Antihemorrhagics
Indacaterol (maleate)/ glycopyrronium
Medicines for obstructive airway diseases
bromide
Insulin degludec / liraglutide
1 Based on the ATC therapeutic sub-group.
Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human UseEMA/21080/2014 International non-proprietary name
Therapeutic area1
(salt, ester, derivative, etc.) / Common
Name
Mixture of polynuclear iron(iii)-oxyhydroxide, Other therapeutic medicinessucrose and starchesNaloxegol (oxalate) Sex hormones and modulators of the genital system Phenylephrine (hydrochloride) / ketorolac trometamol
Pregabalin
Antiepileptics
Safinamide (methanesulfonate)
Anti-parkinson medicines
Other medicines for disorders of the musculo-skeletal Medicines for obstructive airway diseases Medicines for obstructive airway diseases Vorapaxar
Antithrombotic medicines
Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human UseEMA/21080/2014 Non-orphan generic and biosimilar medicinal products
International non-proprietary
name / Common Name
Tadalafil
Urologicals
Orphan medicinal products
International non-
Marketing
proprietary name (salt,
authorisation
ester, derivative, etc.) /
applicant
Common Name
Allogenic human
Heparesc
Cytonet GmbH&Co
Other alimentary tract
heterologous liver cells
and metabolism
products
Dasiprotimut-T
Dasiprotimut
Biovest Europe Ltd
Immunostimulants
-T Biovest
Dinutuximab
Unituxin
United Therapeutics
Antineoplastic
Europe Ltd
medicines
Other alimentary tract and metabolism products 2 Based on the ATC therapeutic sub-group.
3 Based on the ATC therapeutic sub-group.
Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human UseEMA/21080/2014 International non-
Marketing
proprietary name (salt,
authorisation
ester, derivative, etc.) /
applicant
Common Name
Ketoconazole
Ketoconazol
Agenzia industrie
Other therapeutic
e aid-scfm
difesa-stabilimento
medicines
chimico farmaceutico
militare
Levofloxacin
Levofloxacin Aptalis Pharma SAS
Antibacterials for
– Aptalis
systemic use
preparations, excl. sex hormones and insulins sulfatase (rhgalns)
Recombinant L-
Spectrila
Medac Gesellschaft
Antineoplastic
asparaginase
Fuer Klinische
medicines
Spezialpraeparate
MbH
Tolvaptan
Urologicals
Pharmaceutical
Europe Ltd
Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human UseEMA/21080/2014

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