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Product Date Safety information Attachments
Motilium (Domperidone) 2020-10-18

Removal of the paediatric posology and reminder of indication and contraindications related to serious cardiac side-effects

Ecalta (Anidulafungin) 2020-03-11

Ecalta 100mg Powder for Concentrate for Solution for Infusion (Anidulafungin): Solution for Infusion must no longer be frozen

Depakine (Valproate) 2020-02-01

Restrictions on use; pregnancy prevention programme to be put in place.

Kyprolis® ( Carfilzomib) 2019-12-12

Kyprolis (carfilzomib) – New Safety Information: Risk of Progressive Multifocal Leukoencephalopathy (PML) and Hepatitis B Virus (HBV) Reactivation

Esbriet® (Pirfenidone) 2019-12-08

Important Safety Update on ESBRIET® (pirfenidone) and Drug-Induced Liver Injury (DILI)

Arava® -leflunomide 2019-09-25

Risk of serious birth defects when administered during pregnancy

Fingolimod (Gilenya®) 2016-03-21

​Risks related to the effects on the immune system​ . 

Xarelto ® (Rivaroxaban) 2015-12-14

​Warnings and precautions for use to reduce the risk of bleeding.


Motilium® (Domperidone) 2014-09-22

​New recommendations to minimise the cardiac risks . 

Amistop® (Domperidone) 2014-09-14

​New recommendations to minimise the cardiac risks .

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