Black Triangle
What does the black triangle ▼ mean?
Synonym: Black Symbol
The European Union has introduced a way of identifying medicines that are being additionally - i.e. particularly closely - monitored.
These medicines are labelled with a inverted black triangle ▼and the following note is provided:
Summary of Product Characteristics:
"▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions."
Package leaflet:
”▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.”
What does “additional monitoring” mean?
All medicinal products are carefully monitored, because, for example, some less common side effects may only be apparent when a medicinal product is used in a real-life setting for a long time by a larger and more diverse group of patients.
“Additional monitoring” means particularly close monitoring and was introduced in order to:
- keep a closer eye on certain medicinal products (as listed below) and
- support reporting of adverse reactions. These can be reported easily and at any time by anyone. The aim is to identify any risk as soon as possible and thus provide information about further safe and effective use.
„Additional monitoring“ does not mean that the medicinal product is unsafe. In general, only medicinal products are authorised by the authorities (and are only then allowed to enter the market) for which it has been proven that their benefits outweigh their risks.
What categories of medicinal products are affected?
Additional monitoring is provided for medicinal products for which less information is available than for others. Medicinal products that fall into the following categories are affected:
- medicinal products that contain a new active substance that did not appear in any authorised medicinal product in the EU as of 1 January 2011;
- biological medicinal products (such as vaccines or blood products), authorised in the EU after 1 January 2011;
- medicinal products for which the marketing-authorisation holder is required to carry out a post-authorisation safety study (PASS) (for instance, to provide more data on long-term use of the medicinal product or on a rare adverse reaction seen during clinical trials);
- medicinal products given conditional approval or authorised under exceptional circumstances.
- Furthermore, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) may also recommend other medicinal products.
1 “Conditional approval” means that further evidence of benefit for this medicinal product is awaited.
2 “Exceptional circumstances” means that there are special reasons why the marketing authorisation holder cannot provide comprehensive data, e.g.
- due to the rarity of the disease,
- for scientific reasons
- for ethical reasons
The European Medicines Agency reviews new information on medicinal products authorised under conditional approval or exceptional circumstances every year.
The summary of product characteristics and the package leaflet (both only available in German) are provided in the Austrian medicinal product index.
A list of all medicines approved in the EEA under additional monitoring, including the respective reasons, is published on the website of the European Medicines Agency (EMA): List of medicines under additional monitoring.
Further information
Electronic national reporting system of the BASG.
Websites of the European Medicines Agency (EMA):
- Medicines under additional monitoring
- Good pharmacovigilance practices (Guideline on good pharmacovigilance practices: Module X - Additional Monitoring)
