The Prescribing Information, which is the same thing as the Product Label or Package Insert, is a very important document because it represents the “official” facts about a medication as approved by the US Food and Drug Administration.
In Europe, the equivalent document is called the Summary of Product Characteristics, which is abbreviated as SmPC (source), and is approved by the European Medicines Agency, the European equivalent of the FDA.
Australia uses the same term—Prescribing Information—which is approved by the Therapeutic Goods Association (TGA), their equivalent of the FDA.
What changes (updates) have been made?
From time to time, the Prescribing Information is updated with changes that the FDA mandates or approves. These changes are listed in a section titled “Recent Major Changes” (see image below).
Also, the changes are marked in the body of the Prescribing Information by a line in the margin next to the text that has been added or modified, as shown in the image below:
The last part of the Prescribing Information contains the Medication Guide, which is to be given to the patient by the dispensing pharmacy. The date when the Medication Guide was last revised is noted at its end, as illustrated in the image below:
But how do we know that the Prescribing Information we are looking at is the most up-to-date version and has not been revised since then? And, where can we find the latest, most up-to-date version of the Prescribing Information (Package Insert, Product Label) of any medication that is marketed in the USA? We have answered these related questions in the following article on this website:
Where to find the latest, most up-to-date version of the Prescribing Information?
Related Pages
Prescribing Information (Package Insert; Product Label)
What changes (updates) have been made to the Prescribing Information?
Where to find the latest, most up-to-date version of the Prescribing Information?
References
Abilify Prescribing Information. Available at https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c040bd1d-45b7-49f2-93ea-aed7220b30ac&type=display. Accessed on December 8, 2024.
Ablify Summary of Product Characteristics. Available at https://www.ema.europa.eu/en/documents/product-information/abilify-epar-product-information_en.pdf. Accessed on December 8, 2024.
Nathan JP, Vider E. The Package Insert. US Pharm.2015;40(5):8-10. Available at https://www.uspharmacist.com/article/the-package-insert. Accessed on December 8, 2024.
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