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.

Summary of changes in October 2017

The following centrally authorised products have been added to the list:

  • Dupixent (dupilumab): New active substance.
  • Lutathera (lutetium (177Lu) oxodotreotide): New active substance.
  • Rydapt (midostaurin): New active substance.
  • Symtuza (darunavir / cobicistat / emtricitabine / tenofovir alafenamide): New active substance.
  • Tecentriq (atezolizumab): New active substance.

The following centrally-authorised products have been deleted from the list:

  • AMYViD (florbetapir [18F]): Five years following its authorisation, AMYViD is no longer considered a new active substance. It is therefore removed from the list.
  • Betmiga (mirabegron): Five years following its authorisation, Betmiga is no longer considered a new active substance. It is therefore removed from the list.
  • Lyxumia (lixisenatide): Five years following its authorisation, Lyxumia is no longer considered a new active substance. It is therefore removed from this list.
  • Ristempa (pegfilgrastim): At the marketing authorisation holder's request, the marketing authorisation granted by Decision C(2015)2528(final) of 13 April 2015 has been withdrawn on 28 September 2017. Ristempa is therefore removed from the list.
  • Ryzodeg (insulin degludec/insulin aspart): Five years following its authorisation, Ryzodeg is no longer considered a new active substance. It is therefore removed from this list.
  • Tresiba (insulin degludec): Five years following its authorisation, Tresiba is no longer considered a new active substance. It is therefore removed from this list.
  • Zaltrap (aflibercept): Five years following its authorisation, Zaltrap is no longer considered a new active substance. It is therefore removed from the list.

Additionally, following fulfilment of all obligations imposed on the marketing authorisations in the framework of the referral based on Article 31 of Directive 2001/83/EC, trimetazidine-containing medicinal products for human use are no longer under additional monitoring, therefore Annex II - List of trimetazidine-containing medicinal products in the European Union has been removed from the Additional Monitoring list.

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)   2013-04-25 2017-10-25  
List of medicinal products under additional monitoring (English only)   2013-06-23 2017-10-25  
Annex I - List of cyproterone-acetate / ethinylestradiol-containing medicinal products in the European Union (English only)   2013-08-09 2017-10-25  
Annex I - List of cyproterone-acetate / ethinylestradiol-containing medicinal products in the European Union (English only)   2013-08-09 2017-10-25  
Annex III - List of intravenous iron-containing medicinal products in the European Union (English only)   2014-01-29 2017-09-27  
Annex III - List of intravenous iron-containing medicinal products in the European Union (English only)   2014-01-29 2017-09-27  
Annex IV - List of thiocolchicoside-containing medicinal products in the European Union (English only)   2014-01-29 2015-10-26  
Annex IV - List of thiocolchicoside-containing medicinal products in the European Union (English only)   2014-01-29 2015-10-26  
Annex V - List of hydroxyethyl starch (HES)-containing medicinal products in the European Union (English only)   2014-01-29 2017-06-28  
Annex V - List of hydroxyethyl starch (HES)-containing medicinal products in the European Union (English only)   2014-01-29 2017-06-28  
Annex VI - List of flupirtine-containing medicinal products in the EU (English only)   2014-02-26 2017-09-27  
Annex VI - List of flupirtine-containing medicinal products in the EU (English only)   2014-02-26 2017-09-27  
Annex VII - List of Targocid and associated names (teicoplanin-containing medicinal products in the EU) (English only)   2014-02-26    
Annex VII - List of Targocid and associated names (teicoplanin-containing medicinal products in the EU) (English only)   2014-02-26    
Annex VIII - List of cilostazol-containing medicinal products in the European Union (English only)   2014-05-28 2017-07-26  
Annex VIII - List of cilostazol-containing medicinal products in the European Union (English only)   2014-05-28 2017-07-26  
Annex IX - List of combined hormonal contraceptives containing chlormadinone in the European Union (English only)   2014-06-25 2017-09-27  
Annex IX - List of combined hormonal contraceptives containing chlormadinone in the European Union (English only)   2014-06-25 2017-09-27  
Annex X - List of domperidone-containing medicinal products in the European Union (English only)   2014-07-30 2017-09-27  
Annex X - List of domperidone-containing medicinal products in the European Union (English only)   2014-07-30 2017-09-27  
Annex XI -List of Numeta G16%E medicinal products in the European Union (English only)   2014-09-30    
Annex XI - List of Numeta G16%E medicinal products in the European Union (English only)   2014-09-30    
Annex XII - List of Dexamed and associated names (dexamfetamine sulphate-containing medicinal products) in the European Union (English only)   2014-09-30 2017-02-22  
Annex XII - List of Dexamed and associated names (dexamfetamine sulphate-containing medicinal products) in the European Union (English only)   2014-09-30 2017-02-22  
Annex XIII - List of Valproate and related substances in the European Union (English only)   2015-01-28 2017-07-26  
Annex XIII - List of Valproate and related substances in the European Union (English only)   2015-01-28 2017-07-26