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Human medicine European public assessment report (EPAR): Raxone
idebenone, Optic Atrophy, Hereditary, Leber
Date of authorisation: 08/09/2015,
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, 
, Revision: 7, Authorised, Last updated: 02/09/2021
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Human medicine European public assessment report (EPAR): Strensiq
asfotase alfa, Hypophosphatasia
Date of authorisation: 28/08/2015,, , , Revision: 15, Authorised, Last updated: 07/07/2021
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Human medicine European public assessment report (EPAR): Orphacol
cholic acid, Digestive System Diseases; Metabolism, Inborn Errors
Date of authorisation: 12/09/2013,
Date of refusal: 25/05/2012,, , , Revision: 11, Authorised, Last updated: 23/06/2021
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Human medicine European public assessment report (EPAR): Defitelio
defibrotide, Hepatic Veno-Occlusive Disease
Date of authorisation: 18/10/2013,, , , Revision: 13, Authorised, Last updated: 28/01/2021
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Human medicine European public assessment report (EPAR): Atriance
nelarabine, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 22/08/2007,, , Revision: 24, Authorised, Last updated: 04/12/2020
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Human medicine European public assessment report (EPAR): Kolbam
cholic acid, Metabolism, Inborn Errors
Date of authorisation: 20/11/2015,, Revision: 14, Withdrawn, Last updated: 15/07/2020
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Human medicine European public assessment report (EPAR): Vedrop
tocofersolan, Cholestasis; Vitamin E Deficiency
Date of authorisation: 23/07/2009,, , Revision: 13, Authorised, Last updated: 22/08/2019
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Human medicine European public assessment report (EPAR): ATryn
Antithrombin alfa, Antithrombin III Deficiency
Date of authorisation: 28/07/2006,, , Revision: 16, Withdrawn, Last updated: 02/07/2019
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Human medicine European public assessment report (EPAR): Ceplene
Histamine dihydrochloride, Leukemia, Myeloid, Acute
Date of authorisation: 07/10/2008,, , Revision: 12, Authorised, Last updated: 01/08/2018
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Human medicine European public assessment report (EPAR): Glybera
alipogene tiparvovec, Hyperlipoproteinemia Type I
Date of authorisation: 25/10/2012,, , Revision: 8, Withdrawn, Last updated: 30/10/2017
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Human medicine European public assessment report (EPAR): Pumarix
pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) , Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 04/03/2011,, Revision: 4, Withdrawn, Last updated: 17/03/2015
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Human medicine European public assessment report (EPAR): Daronrix
Whole virion, inactivated, containing antigen*: A/Vietnam/1194/2004 (H5N1)* produced in eggs, Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 21/03/2007,, Withdrawn, Last updated: 02/07/2013
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Human medicine European public assessment report (EPAR): Rilonacept Regeneron (previously Arcalyst)
Rilonacept, Cryopyrin-Associated Periodic Syndromes
Date of authorisation: 23/10/2009,, Revision: 5, Withdrawn, Last updated: 30/10/2012
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Human medicine European public assessment report (EPAR): Xigris
drotrecogin alfa (activated), Sepsis; Multiple Organ Failure
Date of authorisation: 22/08/2002,, Revision: 13, Withdrawn, Last updated: 21/02/2012
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Human medicine European public assessment report (EPAR): Onsenal
Celecoxib, Adenomatous Polyposis Coli
Date of authorisation: 17/10/2003,, Revision: 13, Withdrawn, Last updated: 06/04/2011
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Human medicine European public assessment report (EPAR): Evkeeza
Evinacumab, Hypercholesterolemia
Date of authorisation: 17/06/2021,, , Authorised, Last updated: 21/04/2021
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Human medicine European public assessment report (EPAR): Zokinvy (new)
Lonafarnib, Progeria; Laminopathies
Date of authorisation: 18/07/2022,, , , Authorised, Last updated: 01/08/2022
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Direct healthcare professional communication (DHPC): Myalepta (metreleptin): inconsistencies in the package leaflet
Active substance: Metreleptin, DHPC type: Quality defect, Last updated: 18/06/2020 -
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Direct healthcare professional communication (DHPC): Lojuxta (lomitapide): Reminder to monitor the liver function of patients treated with Lojuxta and to avoid use in pregnancy
Active substance: Lomitapide, DHPC type: Post-authorisation measure, Last updated: 17/02/2021 -
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Direct healthcare professional communication (DHPC): Defitelio (defibrotide): Do not use for prophylaxis of veno-occlusive disease (VOD) after post-hematopoietic stem-cell transplantation (HSCT)
Active substance: defibrotide, DHPC type: Lack of effect, Safety signal, Last updated: 13/06/2022