40 results
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Adaptive pathways workshop
European Medicines Agency, UK, 08/12/2016, Last updated: 23/02/2017Generic Presentation - The Salford Lung Study (Ashley Woodcock … -
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National expert: Jens Bate, Federal Institute for Drugs and Medical Devices (updated)
- Declaration of interests - 41.88 KB | PDF
- Curriculum Vitae - 31.89 KB | PDF
Artemed_Fachklinik Prof. Dr. Dr. Salfeld GmbH • Start date: 041999 • … -
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Human medicine European public assessment report (EPAR): Granupas (previously Para-aminosalicylic acid Lucane)
Para-aminosalicylic acid, Tuberculosis
Date of authorisation: 07/04/2014,
, Revision: 11, Authorised, Last updated: 26/04/2023
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Human medicine European public assessment report (EPAR): Enerzair Breezhaler
indacaterol, Glycopyrronium bromide, mometasone, Asthma
Date of authorisation: 03/07/2020, Revision: 4, Authorised, Last updated: 17/03/2023 -
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Human medicine European public assessment report (EPAR): Bemrist Breezhaler
indacaterol, Mometasone furoate, Asthma
Date of authorisation: 30/05/2020, Revision: 5, Authorised, Last updated: 02/02/2023 -
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Human medicine European public assessment report (EPAR): Atectura Breezhaler
indacaterol acetate, Mometasone furoate, Asthma
Date of authorisation: 30/05/2020, Revision: 7, Authorised, Last updated: 02/02/2023 -
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Veterinary medicine European public assessment report (EPAR): Aivlosin
tylvalosin, Pheasants; Chicken; Turkeys; Pigs
Date of authorisation: 09/09/2004, Revision: 33, Authorised, Last updated: 29/03/2021 -
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Human medicine European public assessment report (EPAR): Relvar Ellipta
fluticasone furoate, vilanterol, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 13/11/2013, Revision: 24, Authorised, Last updated: 02/02/2023 -
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Veterinary medicine European public assessment report (EPAR): Reconcile
fluoxetine, Dogs
Date of authorisation: 08/07/2008, Revision: 14, Authorised, Last updated: 16/06/2021 -
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Human medicine European public assessment report (EPAR): Revinty Ellipta
fluticasone furoate, vilanterol trifenatate, Asthma
Date of authorisation: 02/05/2014, Revision: 21, Authorised, Last updated: 02/02/2023 -
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Human medicine European public assessment report (EPAR): Zimbus Breezhaler
Glycopyrronium bromide, Indacaterol (acetate), Mometasone furoate, Asthma
Date of authorisation: 03/07/2020, Revision: 3, Authorised, Last updated: 09/12/2021 -
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Human medicine European public assessment report (EPAR): Galafold (updated)
Migalastat hydrochloride, Fabry Disease
Date of authorisation: 25/05/2016,
, , Revision: 16, Authorised, Last updated: 25/05/2023
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Human medicine European public assessment report (EPAR): Ketoconazole HRA
Ketoconazole, Cushing Syndrome
Date of authorisation: 18/11/2014,, 
, , Revision: 10, Authorised, Last updated: 07/06/2021
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National expert: Alessandro Aiuti, European Medicines Agency (updated)
- Declaration of interests - 47.09 KB | PDF
- Curriculum Vitae - 147.43 KB | PDF
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Referral: Ranitidine-containing medicinal products
ranitidine, Article 31 referrals
Status: European Commission final decision, opinion/position date: 17/09/2020, EC decision date: 24/11/2020, Last updated: 17/02/2021 -
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Orphan designation: (4R,5R)-1-[[4-[[4-[3,3-dibutyl-7-(dimethylamino)-2,3,4,5- tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-1-azoniabicyclo[2.2.2]octane chloride (maralixibat chloride) for: Treatment of Alagille syndrome
Date of designation: 18/12/2013, Positive, Last updated: 14/12/2022 -
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Orphan designation: (4R,5R)-1-[[4-[[4-[3,3-dibutyl-7-(dimethylamino)-2,3,4,5- tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-1-azoniabicyclo[2.2.2]octane chloride (maralixibat chloride) for: Treatment of primary sclerosing cholangitis
Date of designation: 16/01/2014, Withdrawn, Last updated: 14/06/2022 -
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Orphan designation: (4R,5R)-1-[[4-[[4-[3,3-dibutyl-7-(dimethylamino)-2,3,4,5- tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-1-azoniabicyclo[2.2.2]octane chloride (maralixibat chloride) for: Treatment of primary biliary cirrhosis
Date of designation: 16/01/2014, Withdrawn, Last updated: 14/06/2022 -
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Orphan designation: (4R,5R)-1-[[4-[[4-[3,3-dibutyl-7-(dimethylamino)-2,3,4,5- tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-1-azoniabicyclo[2.2.2]octane chloride (maralixibat chloride) for: Treatment of progressive familial intrahepatic cholestasis
Date of designation: 16/01/2014, Positive, Last updated: 03/12/2021 -
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Orphan designation: tripotassium citrate monohydrate, Potassium hydrogen carbonate for: Treatment of distal renal tubular acidosis
Date of designation: 20/06/2017, Withdrawn, Last updated: 03/05/2021kezelése Italian Citrato di potassio monoidrato e bicarbonato di potassio Trattamento dell’ acidosi … -
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Public data from Article 57 database
Last updated: 17/10/2022 -
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Orphan designation: Octreotide chloride for: Treatment of acromegaly
Date of designation: 12/06/2009, Positive, Last updated: 30/05/2018 -
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Orphan designation: [5,10,15,20-tetrakis(4-carboxyphenyl)-21H,23H-porphine]manganese(III) chloride for: Treatment of Cockayne syndrome
Date of designation: 12/01/2017, Positive, Last updated: 13/07/2017 -
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Orphan designation: tegafur, gimeracil, oteracil potassium for: Treatment of gastric cancer
Date of designation: 20/12/2007, Withdrawn, Last updated: 28/03/2011 -
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Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use'
Last updated: 12/09/2022