European Medicines Agency
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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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...
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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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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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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...
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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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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 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...
HTML (261 views) (23 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.
HTML (184 views) (16 Downloads)
European Medicines Agency - documents open for public consultations
Access to EMA documents that are currently open for public consultation.
HTML (159 views) (12 Downloads)
European Medicines Agency - statistics on human medicines
Dataset gives access to monthly figures on centralised procedures for human medicines.
HTML (303 views) (25 Downloads)
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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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...
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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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This search allows the user to find information on referrals for human medicines assessed by the European Medicines Agency (EMA). It includes ongoing and completed referral procedures....
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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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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 (298 views) (12 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...
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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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Medicines under evaluation (Human)
This search lists information on applications for centralised marketing authorisations for human medicines that are under evaluation by the European Medicines Agency's Committee for...
HTML (348 views) (47 Downloads)