List of medicines under additional monitoring

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The list of medicines under additional monitoring includes medicines authorised in the European Union (EU) that are being monitored particularly closely by regulatory authorities. 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.

The list includes centrally and nationally authorised medicines in the following categories:

  • medicines that contain a new active substance that was not contained in any authorised medicine in the EU on 1 January 2011;
  • biological medicines authorised after 1 January 2011 - this applies to all biological medicines including biosimilars;
  • medicines for which the marketing-authorisation holder is required to carry out a post-authorisation safety study (PASS);
  • medicines given conditional approval or authorised under exceptional circumstances and medicines authorised with specific obligations on the recording or monitoring of suspected adverse drug reactions.

A medicine can be included on this list when it is approved for the first time or at any time during its life-cycle.

Medicines containing new active substances or new biologicals remain on the list for five years. Medicines authorised under exceptional circumstances and those with PASSs remain on the list until the conditions have been fulfilled.

In addition to these medicines, medicines can be included on the list at the request of the European Commission or a medicines regulatory authority in an EU Member State after consulting the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC).

More information on additional monitoring is available:

Contents of the list

For each medicine, the list shows:

  • the invented name;
  • the active substance;
  • the reason why the medicine is on the list;
  • the marketing-authorisation holder;
  • a link to the European public assessment report (for centrally authorised medicines).

The Agency published the first version of the list in April 2013. It is updated every month following review by the PRAC.

Updating product information

Marketing-authorisation holders of medicines on the list are required to update the product information to include the new black symbol and explanatory text using the latest version of the product-information template.

Companies responsible for medicines on the list started to include new information in the product information in mid-2013:

  • For new medicines on the list that had an opinion from the Committee for Medicinal Products for Human Use (CHMP) in or after June 2013, marketing-authorisation applicants must use the latest version of the template including the black triangle.
  • For medicines that were already authorised, marketing-authorisation holders had to use the latest version of the template at the next regulatory procedure affecting the product-information template. If there were no such procedures in 2013, companies were required to submit a type-IAIN variation no later than 31 December 2013.

Full details on the implementation are available in these documents:

List of medicines under additional monitoring

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Document(s) Language Status First published Last updated Effective Date
List of medicinal products under additional monitoring (English only)   25/04/2013 25/06/2014  
List of medicinal products under additional monitoring (English only)   14/06/2013 25/06/2014  
Annex I - List of cyproterone-acetate / ethinylestradiol-containing medicinal products in the European Union (English only)   09/08/2013 27/11/2013  
Annex I - List of cyproterone-acetate / ethinylestradiol-containing medicinal products in the European Union (English only)   09/08/2013 27/11/2013  
Annex II - List of trimetazidine containing medicinal products in the European Union (English only)   27/11/2013    
Annex II - List of trimetazidine containing medicinal products in the European Union (English only)   27/11/2013    
Annex III - List of intravenous iron-containing medicinal products in the European Union (English only)   29/01/2014 05/05/2014  
Annex III - List of intravenous iron-containing medicinal products in the European Union (English only)   29/01/2014 05/05/2014  
Annex IV - List of thiocolchicoside-containing medicinal products in the European Union (English only)   29/01/2014    
Annex IV - List of thiocolchicoside-containing medicinal products in the European Union (English only)   29/01/2014    
Annex V - List of hydroxyethyl starch (HES)-containing medicinal products in the European Union (English only)   29/01/2014    
Annex V - List of hydroxyethyl starch (HES)-containing medicinal products in the European Union (English only)   29/01/2014    
Annex VI - List of flupirtine-containing medicinal products in the EU (English only)   26/02/2014 05/05/2014  
Annex VI - List of flupirtine-containing medicinal products in the EU (English only)   26/02/2014 05/05/2014  
Annex VII - List of Targocid and associated names (teicoplanin-containing medicinal products in the EU) (English only)   26/02/2014    
Annex VII - List of Targocid and associated names (teicoplanin-containing medicinal products in the EU) (English only)   26/02/2014    
Annex VIII - List of cilostazol-containing medicinal products in the European Union (English only)   28/05/2014    
Annex VIII - List of cilostazol-containing medicinal products in the European Union (English only)   28/05/2014    
Annex IX - List of combined hormonal contraceptives containing chlormadinone in the European Union (English only)   25/06/2014    
Annex IX - List of combined hormonal contraceptives containing chlormadinone in the European Union (English only)   25/06/2014