Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use
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1 25 April 2014 EMA/237058/2014 Procedure Management and Business Support Division Applications for new human under evaluation by the Committee for Medicinal Products for Human Use April 2014 This document lists information on applications for centralised marketing authorisation for human that the European Medicines Agency has received for evaluation. It includes the international non-proprietary names (INN) and therapeutic areas for all new innovative under evaluation by the Committee for Medicinal Products for Human Use (CHMP). For generic and biosimilar, it includes the INN (active moiety only, with no information on salt, ester or derivative) and therapeutic area. This list only includes information for whose applications have been validated at the time the report was compiled. The information in this report was compiled on 14 April Information on designated orphan 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from this list once the medicine has received a positive or negative opinion from the CHMP or when the applicant has withdrawn the application. The Agency publishes information on these opinions and withdrawn applications on its website.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. 7 Westferry Circus Canary Wharf London E14 4HB United Kingdom Telephone +44 (0) Facsimile +44 (0) info@ema.europa.eu Website An agency of the European Union European Medicines Agency, Reproduction is authorised provided the source is acknowledged.
2 Non-orphan medicinal products International non-proprietary name (salt, ester, derivative, etc.) / Aclidinium (bromide) / formoterol fumarate (dihydrate) Apremilast Balugrastim Bazedoxifene (acetate) / estrogens conjugated Brinzolamide / brimonidine (tartrate) Cangrelor Ceritinib Ciclosporin Clopidogrel (bisulfate) / acetylsalicylic acid Daclatasvir (dihydrochloride) Dalbavancin (hydrochloride) Darunavir (ethanolate) / cobicistat Dolutegravir / abacavir / lamivudine Dulaglutide Edoxaban (tosylate) Faldaprevir Ferric citrate coordination complex Flutemetamol (18F) Guanfacine (hydrochloride) Human alpha1-proteinase inhibitor Human fibrinogen / human thrombin Human papillomavirus vaccine [types 6, 11, 16, 18, 31, 33, 45, 52, 58] (recombinant, adsorbed) Idelalisib Insulin degludec / liraglutide Lamivudine (hydrate) / raltegravir (potassium) Liraglutide Therapeutic area 1 Medicines for obstructive airway diseases Immunosuppressants Sex hormones and modulators of the genital system Antithrombotic Antithrombotic Antibacterials for Antithrombotic Other therapeutic Antihypertensives Vaccines 1 Based on the ATC therapeutic sub-group. Applications for new human under evaluation by the Committee for Medicinal Products for Human Use EMA/237058/2014 Page 2/5
3 International non-proprietary name (salt, ester, derivative, etc.) / Lutetium (177 Lu) (chloride) Mixture of polynuclear iron(iii)-oxyhydroxide, sucrose and starches Naloxegol (oxalate) Naltrexone (hydrochloride) / bupropion (hydrochloride) Netupitant / palonosetron (hydrochloride) Nintedanib Nonacog gamma Oritavancin (diphosphate) Ospemifene Peginterferon beta-1a Perflubutane Phenylephrine (hydrochloride) / ketorolac (trometamol) Safinamide (methanesulfonate) Secukinumab Simoctocog alfa Sofosbuvir / ledipasvir Spheroids of human autologous matrixassociated chondrocytes Tedizolid (phosphate) Tilmanocept Trametinib Vorapaxar Therapeutic area 1 Other therapeutic Medicines for constipation Antiobesity Antiemetics and antinauseants Antibacterials for Sex hormones and modulators of the genital system Contrast media Anti-parkinson Immunosuppressants Other for disorders of the musculo-skeletal system Antibacterials for Antithrombotic Applications for new human under evaluation by the Committee for Medicinal Products for Human Use EMA/237058/2014 Page 3/5
4 Non-orphan generic and biosimilar medicinal products International non-proprietary name / Therapeutic area 2 Total number of applications Budesonide / formoterol Medicines for obstructive 3 airway diseases Busulfan 1 Insulin glargine 1 Tacrolimus Immunosuppressants 1 Tadalafil Urologicals 1 Voriconazole Antimycotics for 1 Orphan medicinal products International nonproprietary name (salt, ester, derivative, etc.) / Product name Marketing authorisation applicant Therapeutic area 3 Afamelanotide Scenesse Clinuvel (UK) Limited Emollients and protectives Allogeneic T cells genetically modified to Zalmoxis MolMed SpA express suicide gene Allogenic human heterologous liver cells Heparesc Cytonet GmbH&Co KG Other alimentary tract and metabolism products Dasiprotimut-t Dasiprotim Biovest Europe Ltd ut-t Biovest Dexamethasone (acetate) Neofordex Laboratoires Ctrs - Boulogne Billancourt Corticosteroids for Dinutuximab Unituxin United Therapeutics Europe Ltd Eliglustat Cerdelga Genzyme Europe BV 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 under evaluation by the Committee for Medicinal Products for Human Use EMA/237058/2014 Page 4/5
5 International nonproprietary name (salt, ester, derivative, etc.) / Product name Marketing authorisation applicant Therapeutic area 3 Ex vivo autologous corneal Holoclar Chiesi Farmaceutici S.p.A. epithelial cells including stem cells Ibrutinib Imbruvica Janssen-Cilag International NV Ketoconazole Ketoconaz ole aidscfm Agenzia Industrie Difesa- Stabilimento Chimico Other therapeutic Farmaceutico Militare Ketoconazole Ketoconaz ole lab hra Laboratoire HRA Pharma Antimycotics for pharma Levofloxacin Levofloxaci n Aptalis Aptalis Pharma SAS Antibacterials for Mifepristone Corluxin FGK Representative Service GmbH Systemic hormonal preparations, excl. sex hormones and insulins Obinutuzumab Gazyva Roche Registration Ltd Olaparib Olaparib AstraZenec AstraZeneca AB a AB Ramucirumab Cyramza Eli Lilly Nederland B.V. Recombinant l-asparaginase Spectrila medac Gesellschaft fuer klinische Spezialpraeparate mbh Tobramycin Vantobra PARI Pharma GmbH Antibacterials for Tolvaptan Jinarc Otsuka Pharmaceutical Europe Ltd Urologicals Applications for new human under evaluation by the Committee for Medicinal Products for Human Use EMA/237058/2014 Page 5/5
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