Patient safety

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This page lists major changes made to the authorisation of medicines, which have been recommended by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) to improve safety for patients.

The page lists patient safety information from the last two years. For a full list of all changes made to a centrally authorised medicine, see its European public assessment report. For information on referrals, see referrals.

Patient safety Last updated
CHMP confirms recommendations for use of Zydelig 22/07/2016
PRAC concludes review of Zydelig and issues updated recommendations for use 08/07/2016
CMDh endorses revocation of authorisations for fusafungine sprays used to treat airway infections 01/04/2016
EMA recommends new safety measures for Zydelig 18/03/2016
EMA confirms recommendations to minimise risk of brain infection PML with Tysabri 26/02/2016
EMA confirms recommendations to minimise ketoacidosis risk with SGLT2 inhibitors for diabetes 26/02/2016
EMA concludes defective device in ROCKET study does not impact Xarelto’s safety 05/02/2016
EMA recommends avoidance of certain hepatitis C medicines and amiodarone together 24/04/2015
Codeine not to be used in children below 12 years for cough and cold 24/04/2015
New restrictions to minimise the risks of effects on heart rhythm with hydroxyzine-containing medicines 27/03/2015
Ambroxol and bromhexine expectorants: safety information to be updated 27/02/2015
GVK Biosciences: European Medicines Agency recommends suspending medicines over flawed studies 23/01/2015
European Medicines Agency recommends measures to reduce risk of heart problems with Corlentor/Procoralan (ivabradine) 21/11/2014
European Medicines Agency recommends further measures to minimise risk of blood vessel blockage with Iclusig 24/10/2014
European Medicines Agency completes review of polymyxin-based medicines 24/10/2014