European Medicines Agency
Data from the Article 57 database on all authorised medicines
The European Medicines Agency (EMA) publishes data from the Article 57 database on all medicines authorised in the European Economic Area (EEA) such as product name, active substance,...
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European Medicines Agency's list of European experts
The European Medicines Agency (EMA) maintains a public list containing details on all European experts who can be involved in the Agency's work. The search in the database allows the...
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European Union Clinical Trials Register
The EU Clinical Trials Register contains information on interventional clinical trials on medicines conducted in the European Union (EU), or the European Economic Area (EEA) which started...
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European Medicines Agency - documents open for public consultations
Access to EMA documents that are currently open for public consultation.
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EudraGMDP is the name for the Union database referred to in article 111(6) of Directive 2001/83/EC and article 80(6) of Directive 2001/82/EC. It contains the following information:...
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The shortages catalogue contains information on medicine shortages that affect or are likely to affect more than one European Union (EU) Member State, where the European Medicines Agency...
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European Union Clinical Trials Register - including Article 45 Paediatric Database
Database containing data on all paediatric studies completed by 26 Jan 2007 that the marketing authorisation holders were obliged to submit to EMA by 2011.
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European Medicines Agency's SME Register
Public register of Small and Medium Enterprise Companies established in the European Economic Area that have submitted a SME declaration to the Agency. Register focuses on companies which...
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Withdrawn applications (Human medicines)
This dataset contains information on the decision by a pharmaceutical company to withdraw an application made to the European Medicines Agency for a human medicine. It includes...
HTML PDF (283 views) (16 Downloads)
Recommendations on medication errors
In order to promote the safe use of medicines, EMA systematically communicates on any additional measure decided upon at EU level to prevent medication errors. The purpose of these...
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EU Veterinary Medicinal Product Database
The EU Veterinary Medicinal Product Database is intended to be a source of information on all medicinal products for veterinary use that have been authorised in the European Union and the...
HTML (597 views) (96 Downloads)
Pending EC decisions (Human medicines)
In this dataset you can find medicines that have been evaluated by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) and are currently pending a...
HTML (278 views) (21 Downloads)
The European Union Telematics Controlled Terms (EUTCT) System
EUTCT is a repository and provider of controlled terms in multiple languages for the ongoing exchange of data between information systems and applications throughout the European...
HTML (543 views) (106 Downloads)
European Medicines Agency - statistics on human medicines
Dataset gives access to monthly figures on centralised procedures for human medicines.
HTML (371 views) (81 Downloads)
European Medicines Agency's document library
This search allows the user to find documents published on the European Medicines Agency's website by title, reference number, document type, document owner and year of publication.
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List of major changes made to the authorisation of medicines, which have been recommended by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) to...
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Rare disease (orphan) designations
Information on rare disease (orphan) designations based on applications that have been assessed by the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP)....
HTML (334 views) (24 Downloads)
Medicines for use outside the EU
This page lists the opinions given by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), in co-operation with the World Health Organization (WHO), on...
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Parallel Distribution (PD) register
The Parallel Distribution (PD) register provides up-to-date information on parallel distribution notices checked by the European Medicines Agency to be in compliance with the conditions...
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PROTECT project - The Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium
The Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium is a collaborative European project that comprises a programme to address limitations of current...
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