12 July 2018 EMA/482350/2018 Corr. Information Management Division
Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use July 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 12 July 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from this list once the medicine has received a positive or negative opinion from the CHMP or when the applicant has withdrawn the application. The Agency publishes information on these opinions and withdrawn applications on its website.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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Based on the ATC therapeutic sub-group. Correction: Angiotensin II (acetate) application was first recorded as being reviewed under EMA’s accelerated assessment programme, which is not the case. i
Non-orphan generic and biosimilar medicinal products International non-proprietary name /
Therapeutic area
i
Common Name
Total number of applications
Adalimumab
Immunosuppressants
2
Ambrisentan
Antihypertensives
2
Atazanavir
Antivirals for systemic use Antineoplastic medicines Other nervous system medicines Antineoplastic medicines Other therapeutic medicines Antineoplastic medicines
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.
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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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.
Mar 15, 2018 - (Article 5(12) (b) of Regulation (EC) No 141/2000 of the European Parliament and of the Council). When a designated orphan medicinal product receives a positive opinion for marketing authorisation from EMA's Committee for Medicinal Pro
Feb 27, 2018 - Tazemetostat for treatment of follicular lymphoma, Quintiles Ireland Limited. 2. Opinions adopted at the first COMP discussion: â¢. Docosahexaenoic acid ethyl ester for treatment of sickle cell disease, TurnKey PharmaConsulting. Irela
Feb 8, 2018 - 30 Churchill Place â Canary Wharf â London E14 5EU â United Kingdom. Telephone +44 (0)20 3660 6000 ... This document provides current information related to the volume and evaluation of marketing authorisation and ... The purpose
Mar 5, 2018 - 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 compile
Jun 22, 2018 - An agency of the European Union. Telephone +44 (0)20 ... Selumetinib for treatment of neurofibromatosis type 1, AstraZeneca AB;. â¢. Synthetic ...
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:.
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.
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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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