Definitions

Provides information on terms such as 'safety alerts' and 'black triangles'

What is a side effect?
Side effects, also known as adverse drug reactions (ADRs), are unwanted symptoms that are linked with taking a medicine. They can range from mild, for e...
Wed, 1 Nov, 2017 at 3:53 PM
What is a discontinued product?
Discontinued products are medicines that are no longer marketed. Pharmaceutical companies will often leave their SmPCs and PILs for discontinued medicine...
Thu, 26 Oct, 2017 at 10:19 AM
What does the black triangle mean?
Some Summaries of Product Characteristics (SmPCs) and Patient Information Leaflets (PILs) have an inverted black triangle symbol  displayed at the top...
Thu, 26 Oct, 2017 at 10:19 AM
What are safety alerts?
Occasionally the medicines regulators (the European Medicines Agency, EMA, or the Medicines and Healthcare Products Regulatory Authority, MHRA) issue spec...
Thu, 1 Sep, 2016 at 10:42 AM
What are risk minimisation materials?
For some medicines, the pharmaceutical company has a regulatory obligation to produce information for healthcare professionals and/or patients that will m...
Thu, 1 Sep, 2016 at 10:51 AM
What is a PIL?
PIL stands for Patient Information Leaflet (known as Package Leaflet or PL) and is the leaflet that is included in the pack with a medicine. The PIL...
Fri, 9 Sep, 2016 at 5:08 PM
What is an SmPC?
SmPC, stands for Summary of Product Characteristics. The SmPC is used by healthcare professionals, such as doctors, nurses and pharmacists, and explains h...
Thu, 26 Oct, 2017 at 10:17 AM