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16 results

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PSUR Repository Date: 04. March 2020 Topics: Pharmakovigilanz Arzneimittelsicherheit Type: Article

The PSUR Repository is a central database at the European Medicines Agency (EMA) for the submission, archiving and management of all periodic safety update reports (PSURs) and the associated process documents (assessment reports, response documents, …

Medicinal Products Date: 26. November 2019 Topics: Licensing Arzneimittelsicherheit Type: Article

Medicinal products are substances that are used to treat diseases, to relieve complaints, or to prevent such diseases or complaints in the first place. This definition applies regardless of whether the medicinal product is administered to humans or …

New information in the topic Pharmacovigilance Date: 11. October 2019 Topics: Arzneimittelsicherheit Type: Article

New information in the topic Pharmacovigilance

New information in the topic clinical trials Date: 11. October 2019 Topics: Arzneimittelsicherheit Type: Article

New information in the topic clinical trials

Application for changing the legal status Date: 26. September 2013 Topics: Pharmakovigilanz Arzneimittelsicherheit Type: Article

Application for changing the legal status

Pharmacovigilance Risk Assessment Committee (PRAC) Date: 19. January 2013 Topics: Arzneimittelsicherheit Pharmakovigilanz Type: Article

The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee is responsible for assessing and monitoring safety issues for human medicines; it is the successor to the Pharmacovigilance Working Party (PhVWP) of the Committee for …