List of medicines under additional monitoring

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:

Summary of changes in September 2018

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

  • Aimovig (erenumab) – New active substance and new biological. Kirsti Villikka (FI)
  • Cablivi (caplacizumab) – New active substance and new biological. Jan Neuhauser (AT)
  • Duzallo (allopurinol / lesinurad) – New active substance. Eva A. Segovia (ES)
  • Halimatoz (adalimumab) – New biological. Ulla Wändel Liminga (SE)
  • Hefiya (adalimumab) – New biological. Ulla Wändel Liminga (SE)
  • Hulio (adalimumab) – New biological. Ulla Wändel Liminga (SE)
  • Hyrimoz (adalimumab) – New biological. Ulla Wändel Liminga (SE)
  • Ilumetri (tildrakizumab) – New active substance and new biological. Brigitte Keller-Stanislawski (DE)
  • Kymriah (tisagenlecleucel) – New active substance, new biological, PASS. Brigitte Keller-Stanislawski (DE)
  • Mepsevii (vestronidase alfa) – New active substance, new biological, authorized under exceptional circumstances.
  • Myalepta (metreleptin )– New active substance, new biological, authorized under exceptional circumstances. Adam Przybylkowski (PL)
  • Nerlynx (neratinib) – New active substance. Menno van der Elst (NL)
  • Onpattro (patisiran) – New active substance. Rhea Fitzgerald (IE)
  • Rxulti (brexpiprazole)– New active substance. Tatiana Magalova (SK)
  • Trazimera (trastuzumab) – New biological. Brigitte Keller-Stanislawski (DE)
  • Veyvondi (vonicog alfa) – New active substance and new biological. Ulla Wändel Liminga (SE)
  • Yescarta (axicabtagene ciloleucel) – New active substance, new biological, PASS. Doris Stenver (DK)

The following non-CAPs have been added to the list up to this time:

  • Influvac Tetra (Influenza virus surface antigens) – New biological.
  • Sublivac Birke (Allergen extract of pollen from Birch) – New biological.
  • Sublivac Bäume (Allergen extract of pollen from Birch, Alder and Hazel) – New biological.

In addition, a new annex has been created following a referral under Article 31 of Directive 2001/83/EC in which a PASS was imposed on the marketing authorisations of medicinal products containing acitretin, alitretinoin and isotretinoin (Annex XIV- Retinoids and related substances). Minor updates to several annexes are also attached.

The following CAPs have been removed from the list until 26 September 2018:

  • The marketing authorisation for MACI has expired following the marketing-authorisation holder’s decision not to apply for a renewal.
  • Conditions for Marketing authorisation for Xagrid has been fulfilled and therefore removed from the list.
  • PASS finalised for Relvar Ellipta and therefore removed from the list.
  • Five years after the European Union Reference Date (EURD) the following products are no longer under additional monitoring:

- NovoEight

- Tybost

- Bexsero

- Invokana

- Opsumit

List of medicines under additional monitoring

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