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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 (1997 views) (1843 Downloads)
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COVID-19-related ongoing observational studies in the EU
Information on ongoing COVID-19-related observational studies in the EU is available in the European Union electronic register of post-authorisation studies (EU PAS Register). Users can...
HTML (289 views) (76 Downloads)
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Medicine data: withdrawn applications (Human medicines)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 Excel XLS (890 views) (825 Downloads)
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European Medicines Agency - documents open for public consultations
Access to EMA documents that are currently open for public consultation.
HTML (1026 views) (919 Downloads)
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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 (1275 views) (1136 Downloads)
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Medicine data: European public assessment reports (EPAR) for human medicines
The EMA publishes an EPAR for every medicine granted a central marketing authorisation by the European Commission following an assessment by the EMA's Committee for Medicinal Products for...
HTML Excel XLS (9369 views) (29 Downloads)
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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...
HTML (1980 views) (1769 Downloads)
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Medicine data: shortages
EMA assesses medicine shortages that affect or are likely to affect more than one EU Member State. Following its assessment, EMA publishes information on specific shortages and provided...
Excel XLSX HTML (1232 views) (1122 Downloads)
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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...
HTML (2911 views) (2628 Downloads)
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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...
HTML (1422 views) (1286 Downloads)
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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 (1299 views) (1178 Downloads)
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Medicine data: referrals for human medicines
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....
Excel XLSX HTML (1098 views) (992 Downloads)
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Medicine data: paediatric investigation plans (PIP)
Information on opinions and decisions adopted by the European Medicines Agency's (EMA) Paediatric Committee (PDCO) on Paediatric Investigation Plans (PIPs) including deferrals and...
Excel XLSX HTML (1258 views) (1099 Downloads)
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EMA Medicine evaluation figures (veterinary medicines)
The European Medicines Agency (EMA) publishes information on the volume and outcome of marketing authorisation and post-authorisation applications for veterinary medicines that it...
PDF HTML (251 views) (207 Downloads)
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EMA Medicine evaluation figures (human medicines)
The European Medicines Agency (EMA) publishes information on the volume and outcome of marketing authorisation and post-authorisation applications for human medicines that it evaluates.
PDF HTML (1991 views) (1821 Downloads)
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EudraGMDP database
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:...
HTML (5786 views) (5008 Downloads)
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Medicine data: periodic safety update report (PSUR) single assessments
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...
Excel XLSX HTML (1119 views) (982 Downloads)
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Medicine data: 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 Excel XLS (1595 views) (74 Downloads)
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Medicine data: 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 Excel XLS (1575 views) (1397 Downloads)