5 October 2017 EMA/661972/2017 Information Management Division
Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use October 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 4 Oct 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from this list once the medicine has received a positive or negative opinion from the CHMP or when the applicant has withdrawn the application. The Agency publishes information on these opinions and withdrawn applications on its website.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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2017-10 INN Report - European Medicines Agency - Europa EU
Oct 5, 2017 - EMA/661972/2017. Information Management Division. Applications for new human medicines under evaluation by the Committee for Medicinal ...
Apr 5, 2018 - 1 i Based on the ATC therapeutic sub-group. Orphan medicinal products. International non-proprietary name (salt, ester, derivative, etc.) / Common Name. Therapeutic area i. Asparaginase. Antineoplastic medicines. Avacopan. Immunosuppres
Jun 23, 2016 - Send a question via our website www.ema.europa.eu/contact ... non-proprietary names (INN) and therapeutic areas for all new ... also available in the monthly reports of the Committee for Orphan Medicinal Products (COMP).
May 4, 2018 - Information Management Division ... The information in this report was compiled on 4 May 2018. Information ... Other nervous system medicines.
Jan 4, 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 author
Nov 28, 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 auth
Jun 16, 2016 - Send a question via our website www.ema.europa.eu/contact ... Internal awareness raising events for 20th anniversary . ..... Social media.
Oct 20, 2016 - identifies key priorities which will need to be implemented in the coming years to 2020. .... European Medicines Agency Health Technology Assessment ... to rate their level of agreement in the areas of education and training, ...
Oct 20, 2016 - In order to ensure that scientific and technical advances efficiently contribute to .... to rate their level of agreement in the areas of education and ...
Jun 16, 2016 - 30 Churchill Place â Canary Wharf â London E14 5EU â United Kingdom ...... and at the meeting with all eligible patient organisations. ...... The PCWP has five topic groups, one of which (social media) is a joint group with ...
Sep 15, 2016 - Adverse events cumulative over time such as weight gain independent of height growth are forcefully unidentified in a shorter than one year ...
Sep 15, 2016 - product marketing authorisation. The most ... Based on the IMS sales data of aripiprazole (2011â2013) was concluded that 386692 ..... remained blinded to the sponsor during the course of the IDMC's unblinded data analysis.
Sep 15, 2016 - 21% and 20% of the patients were hospitalized for the entire 6 ..... corresponding to a hazard ratio of 0.37 (aripiprazole vs placebo) and an ...... plus titration and roll over patients from 31-09-266 going directly to open label.
Jul 7, 2017 - COMMUNITY MARKETING AUTHORISATIONS AND EXTENSIONS. 2.1. Opinions ... Quality. Rapp: E. Werner .... solutions table with EMA and CVMP responses to the recommendations made by the FishMed Plus. Coalition ...
Jun 22, 2016 - Information Management Division ... This document provides current information related to the volume and evaluation of .... Plasma master file.
Feb 9, 2017 - Notification of discontinuation of a paediatric development which is covered by an agreed ... for the following reason(s): (tick all that apply).
Jul 5, 2017 - Send a question via our website www.ema.europa.eu/contact ... non-proprietary names (INN) and therapeutic areas for all new ... also available in the monthly reports of the Committee for Orphan Medicinal Products (COMP).
Jul 4, 2016 - Send a question via our website www.ema.europa.eu/contact ... non-proprietary names (INN) and therapeutic areas for all new ... also available in the monthly reports of the Committee for Orphan Medicinal Products (COMP).
maximises the chances of a successful marketing authorisation. ... marketing authorisation. ⢠inclusion in the public SME ... E-mail [email protected]. Website ...
Jun 19, 2017 - and may also vary during the course of the review. ...... ViiV Healthcare UK Limited; Treatment of Human Immunodeficiency Virus ..... adjunctive administration of brivaracetam, Treatment of paediatric patients with partial.
5 days ago - Guidelines should include more details on the principles of good information design in which content and layout are ... relevance and importance of the QRD template is also acknowledged in this respect as it is the main tool .... databas
