Black triangle products are new drugs and vaccines which are being intensively monitored by the CHM and MHRA in order to confirm the risk/benefit profile of the product.

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The black triangle symbol ▼ is assigned to a product if the drug is a new active substance. A product containing previously licensed active substances may also be monitored if it meets one or more of the following criteria:

• A new combination of active substances
• Administration via a new route of administration or drug delivery system; or
• A significant new indication which may alter the established risk/benefit profile of that drug.

There is no standard time for a product to retain black triangle status, an assessment is usually made following two years of post-marketing experience and the black triangle symbol is not removed until the safety of the drug is well established.

Please report all suspected adverse drug reactions to any medicines with the black triangle symbol against it in the British National Formulary (BNF), MIMS, the ABPI Compendium of Datasheets and Summaries of Product Characteristics.

Click here to see the up-to-date lists by generic name or trade name (PDF format ).]