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COVID-19 medicine shortages - list of national registers for medicine shortages
Supply disruptions or medicine shortages can occur as a result of a temporary lockdown of manufacturing sites in areas affected by COVID-19, travel restrictions impacting exports or an...
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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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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...
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Medicine data: withdrawn applications (Human medicines)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'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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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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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...
HTML (1384 views) (1244 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)
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Substance, product, organisation and referential (SPOR) master data
The service provides access to a list of multilingual master data (terminologies, classification systems, controlled vocabularies) developed in the framework of the implementation of the...
HTML (528 views) (469 Downloads)