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Asian Journal of Pharmaceutical Research
Year : 2019, Volume : 9, Issue : 3
First page : ( 203) Last page : ( 205)
Print ISSN : 2231-5683. Online ISSN : 2231-5691.
Article DOI : 10.5958/2231-5691.2019.00033.9

Black Triangle Drugs

Anuradha V. P*, Joseph Betsy, Jayakrishnan S. S, Ajith B

Department of Pharmacy Pratice, College of Pharmaceutical Sciences, Govt. Medical College Thiruvananthapuram-695011, Kerala, India

*Corresponding Author E-mail: radika1293@gmail.com

Online published on 31 December, 2019.

Abstract

A black triangle appearing after the trade name of a British medicine indicates that the medication is new to the market, or that an existing medicine is being used for a new reason or by a new route of administration. Medicines are being monitored by regulatory authorities in the European Union (EU) are eventually described to be under additional monitoring schemes. Medicines under this additional monitoring will have an inverted Black Triangle displayed in their patient information leaflet and in the information for healthcare professionals called the summary of product characteristics, together with a short sentence “This medicinal product is subject to additional monitoring”. This is because we have relatively limited information about their safety from clinical trials as these trials generally involve only small numbers of eligible patients who take the medicine for a relatively short period of time. Black triangle drugs are denoted by inverted black triangle according to new pharmacovigilance rules published by the European Medicines Agency. A Black Triangle symbol is assigned to any drug or vaccine that have a new active substance or a biosimilar medicine or a new combination of medicines or active substances or a new route of administration or drug-delivery system etc. This helps to encourage reporting of adverse reactions and promote safe drug use.

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Keywords

Additional monitoring, Black triangle, European Medicines Agency, Pharmacovigilance, Reporting.

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