5 July 2017 EMA/430827/2017 Information Management Division
Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use July 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 5 July 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from this list once the medicine has received a positive or negative opinion from the CHMP or when the applicant has withdrawn the application. The Agency publishes information on these opinions and withdrawn applications on its website.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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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).
For a list of RSS readers please refer to our RSS guide and follow the instructions ..... PCWP and HCPWP joint meeting: Workshop on social media - Sep 2016.
Jul 12, 2018 - An agency of the European Union ... This list only includes information for medicines whose applications have been validated at the time the.
Information is selected based on recommendations from consulted patients, consumers ... need one of the following: a modern web browser; a web-based news reader or a ..... person developing the medicine must submit an application to the.
Jul 24, 2017 - Send a question via our website www.ema.europa.eu/contact ... consultation will be published on the European Medicines Agency's website at:.
May 8, 2017 - Information Management Division ... This document provides current information related to the volume and evaluation of .... Plasma master file.
Feb 13, 2017 - Monthly report on application procedures, guidelines and .... of MRLs for new substances under article 3 of Regulation (EC) No 470/2009.
Oct 13, 2017 - applications for initial evaluations, extensions, variations and renewals concerning marketing authorisations (MAs); ... Initial evaluation of marketing authorisation applications. 2014. 2015. 2016 .... Out of scope. 1 Establishment of
Mar 16, 2017 - Information Management Division ... This document provides current information related to the volume and evaluation of .... Plasma master file.
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).
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
Jun 15, 2016 - Agenda - EMA Human Scientific Committees' Working. Parties with Healthcare Professionals' Organisations. (HCPWP) meeting. 15 June 2016, 08:45hrs to 10:30hrs â meeting room: 3E. Chairs: I. Moulon (EMA) and Gonzalo Calvo (HCPWP). 15 Ju
