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 September 2017

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

  • Bavencio (avelumab): New active substance, conditional marketing authorisation.
  • Fotivda (tivozanib): New active substance.
  • Imraldi (adalimumab): New active substance.
  • Insulin lispro Sanofi (insulin lispro): New biological.
  • Kisqali (ribociclib): New active substance.
  • Maviret (glecaprevir / pibrentasvir): New active substance, PASS.
  • Veltassa (patiromer): New active substance.
  • Vosevi (sofosbuvir / velpatasvir / voxilaprevir): New active substance, PASS.
  • Xermelo (telotristat): New active substance.

The following nationally authorised product has been added to the list:

  • Cuvitru 200 mg/ml solution for injection (immunglobulin): New biological.

The following centrally authorised products have been removed from the list:

  • Constella (linaclotide): Five years following its authorisation, Constella is no longer considered a new active substance. It is therefore removed from this list.
  • Cuprymina (copper (64Cu) chloride): Five years following its authorisation, Cuprymina is no longer considered a new active substance. It is therefore removed from this list.
  • Enzepi (pancreas powder): At the marketing authorisation holder's request, the marketing authorisation granted by Decision C(2016)4182(final) for the medicinal product "Enzepi - pancreas powder" was withdrawn on 19 July 2017.
  • Forxiga (dapagliflozin): Five years following its authorisation, Forxiga is no longer considered a new active substance. It is therefore removed from this list.

Additionally, Annex I - List of Cyproterone acetate-Ethinylestradiol containing medicinal products in the European Union, Annex III - List of intravenous iron-containing medicinal products in the European Union, Annex VI - List of flupirtine-containing medicinal products in the European Union, Annex IX - List of combined hormonal contraceptives containing chlormadinone in the European Union and Annex X - List of domperidone-containing medicinal products in the European Union, have been updated.

 

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 2017-09-27  
List of medicinal products under additional monitoring (English only)   2013-06-23 2017-09-27  
Annex I - List of cyproterone-acetate / ethinylestradiol-containing medicinal products in the European Union (English only)   2013-08-09 2017-09-27  
Annex I - List of cyproterone-acetate / ethinylestradiol-containing medicinal products in the European Union (English only)   2013-08-09 2017-09-27  
Annex II - List of trimetazidine containing medicinal products in the European Union (English only)   2013-11-27 2017-05-31  
Annex II - List of trimetazidine containing medicinal products in the European Union (English only)   2013-11-27 2017-05-31  
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