796 results
Keyword Ketoconazole HRA Remove keyword
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Orphan designation: Ketoconazole for: Treatment of Cushing's syndrome
Date of designation: 23/04/2012, Positive, Last updated: 22/09/2020Ketoconazole Overview On 23 April 2012 … Commission to Laboratoire HRA Pharma, France, for ketoconazole for the treatment of Cushing's … treatment of Cushing's syndrome. Ketoconazole has been authorised in the … -
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Human medicine European public assessment report (EPAR): Ketoconazole HRA
Ketoconazole, Cushing Syndrome
Date of authorisation: 18/11/2014,
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, Revision: 10, Authorised, Last updated: 07/06/2021
Ketoconazole HRA Cushing Syndrome … Authorised ketoconazole Overview This is a summary … assessment report (EPAR) for Ketoconazole HRA. It explains how the Agency … -
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Withdrawn application: Ketoconazole AID-SCFM
ketoconazole, date of withdrawal: 23/02/2015, Initial authorisation, Last updated: 20/05/2015Ketoconazole AID-SCFM: Withdrawn applicati … authorisation application for Ketoconazole AID-SCFM ketoconazole) On 23 February 2015 … marketing authorisation for Ketoconazole AID-SCFM, for the treatment … -
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Referral: Ketoconazole-containing medicines
ketoconazole, associated names: Nizoral, Fungoral, Article 31 referrals
Status: European Commission final decision, opinion/position date: 25/07/2013, EC decision date: 11/10/2013, Last updated: 13/06/2014Ketoconazole-containing medicines … marketing authorisations of oral ketoconazole-containing medicines should be suspended … Patients currently taking oral ketoconazole for fungal infections should … -
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Orphan designation: Ketoconazole for: Treatment of granulosa cell tumours
Date of designation: 20/03/2017, Positive, Last updated: 05/05/2017Ketoconazole Overview On 20 March 2017 … Infrecuentes (GETHI), Spain, for ketoconazole for the treatment of granulosa … medicine expected to work? Ketoconazole blocks the activity of enzymes … -
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Orphan designation: Ketoconazole for: Treatment of Cushing's syndrome
Date of designation: 09/08/2012, Positive, Last updated: 26/09/2012Ketoconazole Overview On 9 August 2012 … Farmaceutico Militare, Italy, for ketoconazole for the treatment of Cushing's … information to show that ketoconazole might be of significant benefit … -
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Press release: Ketoconazole HRA recommended for approval in Cushing's syndrome
CHMP, Last updated: 26/09/2014Ketoconazole HRA recommended for approval … marketing authorisation for Ketoconazole HRA ketoconazole) in the treatment of Cushing's … Ketoconazole HRA recommended for approval … -
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Orphan designation: 2S, 4R ketoconazole for: Treatment of Cushing's syndrome
Date of designation: 04/07/2012, Positive, Last updated: 24/07/20122S, 4R ketoconazole Overview On 4 July 2012 … Cortendo AB, Sweden, for 2S, 4R ketoconazole for treatment of Cushing's … information to show that 2S, 4R ketoconazole might be of significant benefit … -
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National expert: Sonja Hrabcik, Austrian Medicines and Medical Devices Agency (updated)
- Declaration of interests - 79.77 KB | PDF
- Curriculum Vitae - 16.42 KB | PDF
Sonja Hrabcik … Sonja Hrabcik … Vitae PERSONAL INFORMATION Sonja Hrabcik WORK EXPERIENCE February … -
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National expert: Kristyna Rehorova Hradilkova, State Institute for Drug Control
- Declaration of interests - 79.13 KB | PDF
- Curriculum Vitae - 18.61 KB | PDF
Kristyna Rehorova Hradilkova … Kristyna Rehorova Hradilkova … INFORMATION Kristyna Rehorova Hradilkova WORK EXPERIENCE January … -
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Press release: European Medicines Agency recommends suspension of marketing authorisations for oral ketoconazole
CHMP, Last updated: 26/07/2013marketing authorisations for oral ketoconazole … Benefit of oral ketoconazole does not outweigh risk of … marketing authorisations for oral ketoconazole Benefit of oral ketoconazole does not outweigh risk of … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 September 2014
CHMP, Last updated: 26/09/2014Ketoconazole HRA … -
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Press release: Record number of medicines for rare diseases recommended for approval in 2014
Last updated: 09/01/2015Viekirax, Ofev, Sylvant, Ketoconazole HRA). This mechanism aims to speed … Viekirax, Ofev, Sylvant, Ketoconazole HRA). This mechanism aims to speed … -
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National expert: Henrique Ramos da Costa, General Directorate of Food and Veterinary (updated)
- Declaration of interests - 79.98 KB | PDF
- Curriculum Vitae - 16.97 KB | PDF
PDF icon application/pdf hramosdacosta_CV_en.pdf Declaration of interests … PDF icon application/pdf hramosdacosta_DI_en.pdf … -
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Orphan designation: Relacorilant for: Treatment of Cushing's syndrome
Date of designation: 29/05/2019, Positive, Last updated: 09/08/2019radiation). The medicines Ketoconazole HRA and Signifor (pasireotide … -
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Opinion/decision on a Paediatric investigation plan (PIP): ellaOne, ulipristal acetate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: P/198/2011, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 30/08/2011, Last updated: 03/10/2011, Compliance check: V, 08/11/2013Contraception Oral use Laboratoire HRA Pharma regulatory@hra-pharma.com … submitted by Laboratoire HRA Pharma on 2 May 2011 under … addressed to Laboratoire HRA Pharma, 15 rue Béranger … -
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Human medicine European public assessment report (EPAR): ellaOne
ulipristal, Contraception, Postcoital
Date of authorisation: 15/05/2009, Revision: 22, Authorised, Last updated: 15/04/2021Application details >Laboratoire HRA Pharma22 15/05/2009 200 avenue … -
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Human medicine European public assessment report (EPAR): Emselex
darifenacin hydrobromide, Urinary Incontinence, Urge, Urinary Bladder, Overactive
Date of authorisation: 22/10/2004, Revision: 23, Authorised, Last updated: 24/11/2020infection, such as ritonavir), or ketoconazole or itraconazole (used to … infection, such as ritonavir), or ketoconazole or itraconazole (used to … -
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Press release: Levonorgestrel and ulipristal remain suitable emergency contraceptives for all women, regardless of bodyweight
CHMP, Last updated: 24/07/20142010; 82: 373–378. Studies HRA2914-507, HRA2914-508, HRA2914-509 and HRA2914-513. For more information on these … 82: 373–378. 6. Studies HRA2914-507, HRA2914-508, HRA2914-509 and HRA2914-513. For more information on these … -
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Human medicine European public assessment report (EPAR): Cresemba
isavuconazole, Aspergillosis
Date of authorisation: 15/10/2015,, Revision: 11, Authorised, Last updated: 09/06/2021
taking any of the following: ketoconazole (an antifungal) high-dose … any of the following: • ketoconazole (an antifungal) • high-dose … -
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Human medicine European public assessment report (EPAR): Toviaz
fesoterodine fumarate, Urinary Bladder, Overactive
Date of authorisation: 20/04/2007, Revision: 23, Authorised, Last updated: 25/05/2021include medicines such as ketoconazole and itraconazole (used to … include medicines such as ketoconazole and itraconazole (used … -
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Human medicine European public assessment report (EPAR): Brilique
ticagrelor, Peripheral Vascular Diseases, Acute Coronary Syndrome
Date of authorisation: 03/12/2010, Revision: 16, Authorised, Last updated: 12/05/2021These are medicines such as ketoconazole (used to treat fungal infections … These are medicines such as ketoconazole (used to treat fungal infections … -
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Orphan designation: mifepristone for: Treatment of Cushing's syndrome secondary to ectopic ACTH secretion
Date of designation: 27/07/2005, Withdrawn, Last updated: 10/02/2017Commission to Laboratoire HRA Pharma, France, for mifepristone … Commission to Laboratoire HRA Pharma, France, for mifepristone … contact details: Laboratoire HRA Pharma 15 rue Béranger … -
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Orphan designation: Mitotane for: Treatment of adrenal cortical carcinoma
Date of designation: 12/06/2002, Expired, Last updated: 19/06/2014Commission to Laboratoire HRA Pharma, France, for mitotane … -
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Human medicine European public assessment report (EPAR): Lysodren
Mitotane, Adrenal Cortex Neoplasms
Date of authorisation: 28/04/2004, Revision: 16, Authorised, Last updated: 29/04/2021