97 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: Fenfluramine hydrochloride for: Treatment of Lennox-Gastaut syndrome
Date of designation: 27/02/2017, Positive, Last updated: 25/04/2023 -
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Orphan designation: Fenfluramine hydrochloride for: Treatment of Dravet syndrome
Date of designation: 18/12/2013, Positive, Last updated: 25/04/2023kezelése Italian Fenfluramina cloridrato Trattamento della sindrome … zespołu Draveta Portuguese Cloridrato de fenfluramina Tratamento … -
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Orphan designation: (S)-6-hydroxy-2,5,7,8-tetramethyl-N-((R)-piperidin-3-yl)chroman-2-carboxamide hydrochloride for: Treatment of Leigh syndrome
Date of designation: 15/10/2014, Positive, Last updated: 27/03/2023 -
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Orphan designation: (S)-6-hydroxy-2,5,7,8-tetramethyl-N-((R)-piperidin-3-yl)chroman-2-carboxamide hydrochloride for: Treatment of mitochondrial encephalomyopathy, lactic acidosis and stroke-like episodes
Date of designation: 10/08/2015, Positive, Last updated: 27/03/2023 -
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Orphan designation: apomorphine hydrochloride for: Treatment of off-periods in Parkinson's disease not responding to oral treatment
Date of designation: 16/02/2006, Positive, Last updated: 28/02/2023 -
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Referral: Metoclopramide-containing medicines
metoclopramide, associated names: Maxolon, Primperan, Article 31 referrals
Status: European Commission final decision, opinion/position date: 24/10/2013, EC decision date: 20/12/2013, Last updated: 06/02/2014 -
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Orphan designation: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt (momelotinib) for: Treatment of primary myelofibrosis
Date of designation: 05/08/2011, Positive, Last updated: 04/10/2022 -
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Orphan designation: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt (momelotinib) for: Treatment of post-polycythaemia vera myelofibrosis
Date of designation: 05/08/2011, Positive, Last updated: 04/10/2022 -
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Orphan designation: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt (momelotinib) for: Treatment of post-essential thrombocythaemia myelofibrosis
Date of designation: 05/08/2011, Positive, Last updated: 04/10/2022 -
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Orphan designation: Ponatinib hydrochloride for: Treatment of gastrointestinal stromal tumours
Date of designation: 15/01/2015, Withdrawn, Last updated: 18/03/2022