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Italian Medicines Agency Agenzia Italiana del Farmaco

Medicinal products subject to additional monitoring

Medicinal products subject to additional monitoring

Medicines subject to close and specific monitoring by regulatory agencies.
These are, in particular:

medicines containing new active substances authorised in Europe after 1 January 2011;
all biological medicines (such as vaccines and plasma derivatives), including biosimilars, authorised after 1 January 2011;
medicinal products for which the marketing authorisation holder is required to carry out a post-authorisation safety study (PASS);
medicinal products subject to post-authorisation safety studies (results on long-term use or rare adverse reactions observed during the clinical trial);
medicines whose authorisation is subject to special conditions (where the company that markets the medicine must provide additional data) or authorised under exceptional circumstances (where there are specific reasons why the company cannot provide a comprehensive set of data) and medicines authorised with specific obligations on the recording and monitoring of suspected adverse drug reactions.

Other medicines may be subject to additional monitoring upon decision of the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA).

These medicinal products are labelled with a black symbol, an inverted equilateral triangle, to be included in the package leaflets and the Summary of Product Characteristics together with a standard wording to inform patients and healthcare professionals that the medicinal product is subject to additional monitoring.
 

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