5 April 2018 EMA/216799/2018 Information Management Division
Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use April 2018
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 April 2018. 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from this list once the medicine has received a positive or negative opinion from the CHMP or when the applicant has withdrawn the application. The Agency publishes information on these opinions and withdrawn applications on its website.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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2018-04 INN Report - European Medicines Agency - Europa EU
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. Immunosuppressants. Axicabtagene ciloleucel. Antineoplastic medicines.
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.
Oct 5, 2017 - EMA/661972/2017. Information Management Division. Applications for new human medicines under evaluation by the Committee for Medicinal ...
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.
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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 ...
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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).
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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.
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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
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