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 November 2017

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

  • Cyltezo (adalimumab): New biological.
  • Ontruzant (trastuzumab): New biological.
  • Tookad (padeliporfin): New active substance.
  • Tremfya (guselkumab): New active substance.
  • VeraSeal (human fibrinogen / human thrombin): New biological.
  • Zejula (niraparib): New active substance.

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

  • Ozanex (ozenoxacin): New active substance.

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

  • Edistride (dapagliflozin): Five years after the European Union Reference Date (EURD) for dapagliflozin, Edistride is no longer under additional monitoring. It is therefore removed from this list.
  • Evarrest (human fibrinogen / human thrombin): At the marketing authorisation holder's request, the marketing authorisation granted by Decision C(2013)6344(final) for "EVARREST - Human fibrinogen/Human thrombin" has been withdrawn on 15 November 2017.
  • Selincro (nalmefene): Five years following its authorisation, Selincro is no longer considered a new active substance. It is therefore removed from this list.

The following nationally-authorised product has been deleted from the list:

  • Geonistin tablete za rodnicu (oxytetracyclin, nistatin): The Post Authorisation Safety Study (PASS) previously imposed on Geonistin tablete za rodnicu has been completed, therefore this medicinal product is no longer under additional monitoring.

Additionally, Annex I - List of Cyproterone acetate-Ethinylestradiol containing medicinal products in the European Union and Annex III - List of intravenous iron-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 2017-11-29  
List of medicinal products under additional monitoring (English only)   2013-06-23 2017-11-29  
Annex I - List of cyproterone-acetate / ethinylestradiol-containing medicinal products in the European Union (English only)   2013-08-09 2017-11-29  
Annex I - List of cyproterone-acetate / ethinylestradiol-containing medicinal products in the European Union (English only)   2013-08-09 2017-11-29  
Annex III - List of intravenous iron-containing medicinal products in the European Union (English only)   2014-01-29 2017-11-29  
Annex III - List of intravenous iron-containing medicinal products in the European Union (English only)   2014-01-29 2017-11-29  
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