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 (736 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 (551 weergaven) (159 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Medicine data: withdrawn applications (Human medicines)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 (465 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 (459 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 (443 weergaven) (11 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...
HTML (223 weergaven) (23 Downloads)