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Applications for new human medicines under evaluation april 2013

Applications for new human medicines under evaluationby the Committee for Medicinal Products for Human UseApril 2013 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 4th April 2013.
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from this list once the medicine has received a positive or negative opinion from the CHMP or when the applicant has withdrawn the application. The Agency publishes information on these opinions and withdrawn applications on its website.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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Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7129
E-mail info@ema.europa.eu Website www.ema.europa.eu
European Medicines Agency, 2013. Reproduction is authorised provided the source is acknowledged.
Non-orphan medicinal products
International non-proprietary name
(salt, ester, derivative, etc.) / Common
Name

Albiglutide
Medicines used in diabetes
(hydrochloride)Alogliptin (benzoate) / pioglitazone (hydrochloride)Aripiprazole (monohydrate) Other medicines for disorders of the musculo-skeletal system cells, including autologous cd54+ cells activated with pap-gm-csfAvanafil Sex hormones and modulators of the genital system Canagliflozin / metformin
Medicines used in diabetes
Other medicines for disorders of the musculo-skeletal Dapagliflozin (propanediol monohydrate) / metformin (hydrochloride)Dextromethorphan (hydrobromide)/quinidine (sulfate)Dolutegravir Empagliflozin
Medicines used in diabetes
1 Based on the ATC therapeutic sub-group.
Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human UseEMA/224612/2013 International non-proprietary name
Therapeutic area1
(salt, ester, derivative, etc.) / Common
Name

Fluticasone furoate / vilanterol (trifenatate) Medicines for obstructive airway diseases Human coagulation factor VIII / human von Willebrand factorHuman fibrinogen / human thrombin Medicines for obstructive airway diseases bromideInfluenza vaccine (tetravalent live oxyhydroxide, sucrose and starchesModified vaccinia ankara virus Ospemifene
Sex hormones and modulators of the genital
system

Propranolol
Beta blocking medicines
Pituitary and hypothalamic hormones and analogues Other medicines for disorders of the musculo-skeletal Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human UseEMA/224612/2013 International non-proprietary name
Therapeutic area1
(salt, ester, derivative, etc.) / Common
Name

Medicines for obstructive airway diseases (trifenatate)
Vedolizumab
Immunosuppressants
Non-orphan generic and biosimilar medicinal products
International non-proprietary
Total number of
name / Common Name
applications
Budesonide / formoterol
Medicines for obstructive airway
diseases
Sex hormones and modulators of the genital 2 Based on the ATC therapeutic sub-group.
Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human UseEMA/224612/2013 Orphan medicinal products
International non-
Marketing
proprietary name (salt,
authorisation
ester, derivative, etc.) /
applicant
Common Name
Ex vivo autologous
Holoclar
Chiesi Farmaceutici
Ophthalmologicals
corneal epithelial cells
including stem cells
Folic acid
3 Based on the ATC therapeutic sub-group.
Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human UseEMA/224612/2013

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