2911 results
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Human medicine European public assessment report (EPAR): Hefiya (updated)
adalimumab, Spondylitis, Ankylosing; Hidradenitis Suppurativa; Psoriasis; Arthritis, Juvenile Rheumatoid; Uveitis
Date of authorisation: 26/07/2018,
, Revision: 14, Authorised, Last updated: 20/09/2023
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Human medicine European public assessment report (EPAR): Amglidia
glibenclamide, Diabetes Mellitus
Date of authorisation: 24/05/2018,
, Revision: 6, Authorised, Last updated: 05/07/2023
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Human medicine European public assessment report (EPAR): Myalepta
Metreleptin, Lipodystrophy, Familial Partial
Date of authorisation: 29/07/2018,
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, Revision: 8, Authorised, Last updated: 29/06/2023
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Human medicine European public assessment report (EPAR): Imraldi
adalimumab, Spondylitis, Ankylosing; Arthritis, Rheumatoid; Uveitis; Colitis, Ulcerative; Psoriasis; Arthritis, Psoriatic; Crohn Disease; Hidradenitis Suppurativa; Arthritis
Date of authorisation: 24/08/2017,, Revision: 20, Authorised, Last updated: 24/03/2023
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Human medicine European public assessment report (EPAR): Inovelon
Rufinamide, Epilepsy
Date of authorisation: 16/01/2007, Revision: 23, Authorised, Last updated: 22/02/2023 -
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Human medicine European public assessment report (EPAR): Strensiq
asfotase alfa, Hypophosphatasia
Date of authorisation: 28/08/2015,, , , Revision: 16, Authorised, Last updated: 15/02/2023
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Human medicine European public assessment report (EPAR): Exjade
deferasirox, beta-Thalassemia; Iron Overload
Date of authorisation: 28/08/2006,, Revision: 51, Authorised, Last updated: 22/12/2022
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Human medicine European public assessment report (EPAR): Ivemend
fosaprepitant, Vomiting; Cancer
Date of authorisation: 11/01/2008, Revision: 24, Authorised, Last updated: 26/08/2022 -
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Human medicine European public assessment report (EPAR): Rapamune
Sirolimus, Graft Rejection; Kidney Transplantation
Date of authorisation: 13/03/2001, Revision: 46, Authorised, Last updated: 25/07/2022 -
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Human medicine European public assessment report (EPAR): Votubia
everolimus, Tuberous Sclerosis
Date of authorisation: 02/09/2011, Revision: 30, Authorised, Last updated: 27/06/2022 -
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Human medicine European public assessment report (EPAR): Sprycel
dasatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 20/11/2006, Revision: 41, Authorised, Last updated: 17/06/2022 -
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Human medicine European public assessment report (EPAR): Zebinix
eslicarbazepine acetate, Epilepsy
Date of authorisation: 21/04/2009, Revision: 31, Authorised, Last updated: 14/03/2022 -
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Human medicine European public assessment report (EPAR): Twinrix Paediatric
hepatitis A virus (inactivated), hepatitis B surface antigen, Immunization; Hepatitis B; Hepatitis A
Date of authorisation: 10/02/1997, Revision: 23, Authorised, Last updated: 14/01/2022 -
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Human medicine European public assessment report (EPAR): Halimatoz
adalimumab, Hidradenitis Suppurativa; Psoriasis; Arthritis, Juvenile Rheumatoid; Uveitis; Arthritis, Rheumatoid; Spondylitis, Ankylosing; Arthritis, Psoriatic
Date of authorisation: 26/07/2018,, , Revision: 8, Withdrawn, Last updated: 29/01/2021
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Human medicine European public assessment report (EPAR): Alpivab
Peramivir, Influenza, Human
Date of authorisation: 13/04/2018,, Revision: 2, Withdrawn, Last updated: 09/12/2020
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Human medicine European public assessment report (EPAR): Pedmarqsi
Sodium thiosulfate, Ear Diseases; Ototoxicity
Date of authorisation: 26/05/2023, Authorised, Last updated: 02/06/2023 -
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Withdrawn application: Enthryv
date of withdrawal: 30/06/2014, Initial authorisation, Last updated: 06/11/2014 -
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Withdrawn application: Loulla
mercaptopurine, date of withdrawal: 19/12/2012, Initial authorisation, Last updated: 18/01/2013 -
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Withdrawn application: Fluad Paediatric
date of withdrawal: 10/02/2012, Initial authorisation, Last updated: 24/04/2012 -
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Withdrawn application: Theraloc
date of withdrawal: 01/12/2008, Initial authorisation, Last updated: 04/12/2008 -
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Withdrawn application: NutropinAq
somatropin, date of withdrawal: 24/01/2008, Post-authorisation, Last updated: 28/01/2008 -
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Referral: Intravenous iron-containing medicinal products
ferric carboxymaltose, iron dextran, sodium ferric gluconate, iron isomaltoside, iron sucrose, Article 31 referrals
Status: European Commission final decision, opinion/position date: 27/06/2013, EC decision date: 13/09/2013, Last updated: 28/07/2021 -
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Referral: Retinoid-containing medicinal products
acitretin, adapalene, alitretinoin, bexarotene, isotretinoin, tretinoin, tazarotene, associated names: Targretin, Panretin, Article 31 referrals
Status: European Commission final decision, opinion/position date: 22/03/2018, EC decision date: 21/06/2018, Last updated: 02/07/2018 -
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Referral: Valproate and related substances
sodium valproate, valproate magnesium, valproate semisodium, valproic acid, valpromide, associated names: Absenor, Convival Chrono, Convulex, Delepsine, Depakin, Depakine, Depakote, Depamag, Depamide, Deprakine, Diplexil, Dipromal, Epilim, Episenta, Epival, Ergenyl, Espa-Valept, Hexaquin, Kentlim, Leptilan, Micropakine L.P., Orfiril, Petilin, Valepil, Valhel PR, Valpal, Valpro and Valprolek, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/03/2018, EC decision date: 31/05/2018, Last updated: 07/06/2018 -
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Referral: Symbioflor 2
escherichia coli bacteria (cells and autolysate), associated names: Symbioflor E. Coli, Symbioflor® 2, Symbioflor Escherichia, Article 31 referrals
Status: European Commission final decision, EC decision date: 22/06/2017, Last updated: 07/09/2017