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What does the black triangle mean?

In the European Union (EU), medicines that are being monitored particularly closely by regulatory authorities are labelled with a black inverted triangle () in the product information. These medicines are described as being under 'additional monitoring'. The European Medicines Agency (EMA) maintains a list of all medicines that are under additional monitoring in the EU.

Medicines under additional monitoring have a black inverted triangle displayed in their package leaflet and in the information for healthcare professionals called the summary of product characteristics, together with a short sentence explaining what the triangle means:

Additional monitoring icon This medicinal product is subject to additional monitoring.

The symbol does not appear on the outer packaging or labelling of medicines.

Additional monitoring aims to enhance reporting of suspected adverse drug reactions for medicines for which the clinical evidence base is less well developed. The main goals are to collect information as early as possible to further inform the safe and effective use of these medicines and their benefit-risk profile when used in everyday medical practice.

The concept of additional monitoring was introduced by the 2010 pharmacovigilance legislation, which came into effect in July 2012. The black triangle started appearing in the package leaflets of the medicines concerned from the autumn of 2013.

What the black triangle means

All medicines are carefully monitored after they are placed on the EU market. If a medicine is labelled with the black triangle, this means that it is being monitored even more intensively than other medicines.

This is generally because there is less information available on it than on other medicines, for example because it is new to the market or there is limited data on its long-term use.

It does not mean that the medicine is unsafe.

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List of medicines under additional monitoring

The up-to-date list of medicines under additional monitoring is available on EMA's website and is also published by the national competent authorities in the EU Member States. The list is reviewed every month by the PRAC:

A medicine can be included on this list when it is approved for the first time or at any time during its life cycle. A medicine remains under additional monitoring for five years or until the PRAC decides to remove it from the list.

There may be a delay between the decision to add or remove a medicine from this list and the time when the updated package leaflet comes into circulation. This is because it takes some time for the updated package leaflet to gradually substitute older stock already on the EU market.

Source: https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/medicines-under-additional-monitoring

UK - Black Triangle

Source: https://www.gov.uk/guidance/the-yellow-card-scheme-guidance-for-healthcare-professionals#black-triangle-scheme

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