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The Prescribing Information follows one of two formats: "physician labeling rule" format or "old" (non-PLR) format. For "old" format labeling a "product title" may be listed first and may include the proprietary name (if any), the nonproprietary name, dosage form(s), and other information about the product.
* Drugs@FDA includes information about drugs, including biological products, approved for human use in the United States (see FAQ), but does not include information about FDA-approved products regulated by the Center for Biologics Evaluation and Research (for example, vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products).
Structured Product Labeling (SPL) is a Health Level Seven International (HL7) standard which defines the content of human prescription drug labeling in an XML format. [1] The "drug labeling" includes all published material accompanying a drug, such as the Prescribing Information which contains a great deal of detailed information about the drug.
There are three major licensing authorities that make drug information online accessible: the European Medicines Agency (EMA, EU), and the Food and Drug Administration (FDA, US). The FDA "Label Information" and the EMA "Product Information", where available, are very detailed.
[[Category:Medication templates]] to the <includeonly> section at the bottom of that page. Otherwise, add <noinclude>[[Category:Medication templates]]</noinclude> to the end of the template code, making sure it starts on the same line as the code's last character.
The Compendium of Pharmaceuticals and Specialties: The Canadian Drug Reference for Health Professionals, more commonly known by its abbreviation CPS, [1] is a reference book that contains drug monographs and numerous features which help healthcare professionals prescribe and use drugs safely and appropriately.
Medication therapy management, generally called medicine use review in the United Kingdom, is a service provided typically by pharmacists, medical affairs, and RWE scientists that aims to improve outcomes by helping people to better understand their health conditions and the medications used to manage them. [1]
The FDA determines as part of the drug approvals process that a REMS is necessary, and the drug company develops and maintains the individual program. [2] REMS applies only to specific prescription drugs, but can apply to brand name or generic drugs. REMS for generic drugs may be created in collaboration with the manufacture of the brand name ...