Drug Safety Databases
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Cumulative overview of all ATC (Anatomical Therapeutic Chemical) alterations performed in the period 2005 to 2018. The year changed is when the alterations were implemented in the ...
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Drugs are classified in groups at five different levels. The drugs are divided into fourteen main groups (1st level), with pharmacological/therapeutic subgroups (2nd level). The 3r...
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The primary objective of the Antimicrobial Use option is to facilitate risk-adjusted inter- and intra-facility benchmarking of antimicrobial usage. A secondary objective is to eval...
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The publication Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book) identifies drug products approved on the basis of safe...
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The publication Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book) identifies drug products approved on the basis of safe...
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The publication Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book) identifies drug products approved on the basis of safe...
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Approved Risk Evaluation and Mitigation Strategies Materials (REMS) dataset lists all materials related to REMS process. REMS include a risk mitigation goal, and are comprised of i...
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Approved Risk Evaluation and Mitigation Strategies Products dataset lists all drugs related to REMS process. REMS include a risk mitigation goal, and are comprised of information c...
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The ATC (Anatomical Therapeutic Chemical) classification system divides drugs into different groups according to the organ or system on which they act, their therapeutic intent or ...
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In order to foster transparency and encourage information sharing within the clinical research community, FDA’s (Food and Drug Administration) Center for Drug Evaluation and Rese...