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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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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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 (686 weergaven) (45 Downloads)
Medicine data: referrals for veterinary medicines
The database allows the user to find information on referrals for veterinary medicines assessed by the European Medicines Agency (EMA). A referral is a procedure used to resolve issues...
Excel XLSX HTML (516 weergaven) (159 Downloads)
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 (484 weergaven) (22 Downloads)
Medicine data: withdrawn applications (Human medicines)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 (436 weergaven) (25 Downloads)
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 (430 weergaven) (3 Downloads)
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 (418 weergaven) (11 Downloads)
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,...
Excel XLSX HTML (369 weergaven) (54 Downloads)
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...
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