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 April 2018
The following centrally-authorised products have been added to the list:
- Alofisel (darvadstrocel): New active substance.
- Lamzede (velmanase alfa): New active substance, authorised under exceptional circumstances.
- Lokelma (sodium zirconium cyclosilicate): New active substance.
- Segluromet (ertugliflozin / metformin hydrochloride): New active substance.
- Semglee (insulin glargine): New biological.
- Shingrix (herpes zoster vaccine (recombinant, adjuvanted)): New active substance.
- Steglatro (ertugliflozin): New active substance.
- Steglujan (ertugliflozin / sitagliptin): New active substance.
The following centrally-authorised products have been deleted from the list:
- Enurev Breezhaler (glycopyrronium bromide): The Post Authorisation Safety Study (PASS) previously imposed on Enurev Breezhaler has been completed, therefore this medicinal product is no longer under additional monitoring.
- Raplixa (human fibrinogen / human thrombin): At the marketing authorisation holder‘s request, the marketing authorisationgranted by Decision C(2015)2007(final) for “Raplixa – human fibrinogen / human thrombin”, has been withdrawn on 27 March 2018.
- Seebri Breezhaler (glycopyrronium bromide): The Post Authorisation Safety Study (PASS) previously imposed on Seebri Breezhaler has been completed, therefore this medicinal product is no longer under additional monitoring.
- Tovanor Breezhaler (glycopyrronium bromide): The Post Authorisation Safety Study (PASS) previously imposed on Tovanor Breezhaler has been completed, therefore this medicinal product is no longer under additional monitoring.
- Vibativ (telavancin): At the marketing authorisation holder‘s request, the marketing authorisation granted by Decision C(2011)6341(final) for “Vibativ – telavancin”, has been withdrawn on 23 March 2018.
- Zinbryta (daclizumab): At the marketing authorisation holder‘s request, the marketing authorisation granted by Decision C(2016)4260(final) for “Zinbryta – daclizumab beta”, has been withdrawn on 27 March 2018.
The following nationally-authorised products have been added to the list:
- ENANPLUS (also known in some EU countries as Skudexa, Skudexum and Lenizak), (tramadol hydrochloride/ dexketoprofen): Post Authorisation Safety Study (PASS).
- Ragwizax (standardised allergen extract of pollen from short ragweed (ambrosia artemisiifolia)): New Biological.
- TAKUDEX (also known in some EU countries as Dextra) (tramadol hydrochloride/ dexketoprofen): Post Authorisation Safety Study (PASS).
The following nationally-authorised product has been deleted from the list:
- Influsplit Tetra (influenza virus inactivated split virion): Five years after the Union Reference Date (EURD) referred to in Art 107c(5) of Directive 2001/83/EC, Influsplit Tetra can be removed from the additional monitoring list.