This section is dedicated to bringing you information related to the safety of medicines. This safety information consists of:
These are letters that are issued by the Medicines Authority and are placed on the website for patients and healthcare professionals. For a list of circulars click here. The Medicines Authority operates a notification system where you can subscribe and be notified by SMS and e-mail about any new information related to safety including warnings, alerts and product recalls.
Direct Healthcare Professional Communications are letters addressed to Healthcare Professionals that Marketing Authorisation Holders send by post or email on issues related to the safe and effective use of medicines. To search for ARCHIVED DHPCs click here.
Risk minimisation measures are educational materials that are given to healthcare professionals and/or to patients so that they can understand the risk associated with a medicine and the ways in which the risk can be minimised. These can include leaflets brochures and training, and/or restrictions in prescribing and dispensing. Not all medicines have additional risk minimisation measures. Over time, more than one risk minimisation measure may be associated with a particular medicine as more safety information is gathered through pharmacovigilance.
The Medicines Authority has created a list of products for which risk minimisation measures have been devised and approved. This can help you know if there is additional information related to the safety of your medicines. To search for ARCHIVED Risk Minimisation Measures click here.
The list of medicines under additional monitoring includes medicines authorised in the European Union (EU) that are being monitored particularly closely by regulatory authorities is available here. Medicines under additional monitoring have a black inverted triangle displayed in their package leaflet and summary of product characteristics, together with a short sentence explaining what the triangle means. For more information on the black triangle and additional monitoring please click here.
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