703 results
Keyword Ketoconazole HRA Remove keyword
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Orphan designation: Ketoconazole for: Treatment of Cushing's syndrome
Date of first decision: 23/04/2012, Positive, Last updated: 22/09/2020Commission to Laboratoire HRA Pharma, France, for ketoconazole for the treatment of Cushing's … treatment of Cushing's syndrome. Ketoconazole has been authorised in the … been authorised in the EU as Ketoconazole … -
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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: 10/01/2020
Ketoconazole HRA Cushing Syndrome … Ketoconazole HRA … Ketoconazole HRA, INN ketoconazole 30 Churchill Place … -
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Withdrawn application: Ketoconazole AID-SCFM
ketoconazole, date of withdrawal: 23/02/2015, Initial authorisation, Last updated: 20/05/2015Ketoconazole AID-SCFM: Withdrawn applicati … authorisation application for Ketoconazole AID-SCFM ketoconazole) On 23 February 2015 … marketing authorisation for Ketoconazole AID-SCFM, for the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 … Ketoconazole-containing medicines … Ketoconazole Art 31 referral_13-03_public … -
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Orphan designation: Ketoconazole for: Treatment of granulosa cell tumours
Date of first decision: 20/03/2017, Positive, Last updated: 05/05/2017Infrecuentes (GETHI), Spain, for ketoconazole for the treatment of granulosa … medicine expected to work? Ketoconazole blocks the activity of enzymes … action of these enzymes, ketoconazole is expected to reduce the … -
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Orphan designation: Ketoconazole for: Treatment of Cushing's syndrome
Date of first decision: 09/08/2012, Positive, Last updated: 26/09/2012Farmaceutico Militare, Italy, for ketoconazole for the treatment of Cushing's … information to show that ketoconazole might be of significant benefit … medicine expected to work? Ketoconazole is an antifungal medicine … -
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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 … Ketoconazole HRA recommended for approval … Ketoconazole HRA recommended for approval … -
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Orphan designation: 2S, 4R ketoconazole for: Treatment of Cushing's syndrome
Date of first decision: 04/07/2012, Positive, Last updated: 24/07/2012Cortendo AB, Sweden, for 2S, 4R ketoconazole for treatment of Cushing's … information to show that 2S, 4R ketoconazole might be of significant benefit … expected to work? 2S, 4R ketoconazole is closely related to … -
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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
Vitae PERSONAL INFORMATION Sonja Hrabcik WORK EXPERIENCE February … Hrabcik 2020-12-16 Classified as … declaration of interests I, Sonja Hrabcik Organisation/Company: Austrian … -
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National expert: Kristyna Rehorova Hradilkova, State Institute for Drug Control
- Declaration of interests - 79.13 KB | PDF
- Curriculum Vitae - 17.73 KB | PDF
INFORMATION Kristyna Rehorova Hradilkova WORK EXPERIENCE January … adapt to it through Twist1.Hradilkova K, Maschmeyer P, Westendorf … AB, Zimmermann J, Fang Z, Hradilkova K, Bardua M, Westendorf … -
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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 … marketing authorisations for oral ketoconazole … 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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Orphan designation: Relacorilant for: Treatment of Cushing's syndrome
Date of first decision: 29/05/2019, Positive, Last updated: 09/08/2019radiation). The medicines Ketoconazole HRA and Signifor (pasireotide … -
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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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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, 08/11/2013public enquiries 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: 21, Authorised, Last updated: 26/05/2020Marketing-authorisation holder Laboratoire HRA Pharma Revision 21 Date of … -
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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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Referral: Emergency contraceptives
levonorgestrel, ulipristal acetate, associated names: Norlevo, Levonelle/Postinor and Levodonna, ellaOne, Article 31 referrals
Status: European Commission final decision, opinion/position date: 24/07/2014, EC decision date: 30/09/2014, Last updated: 24/10/201482: 373–378. 6. Studies HRA2914-507, HRA2914-508, HRA2914-509 and HRA2914-513. For more information on these … -
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Orphan designation: mifepristone for: Treatment of Cushing's syndrome secondary to ectopic ACTH secretion
Date of first decision: 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 first decision: 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): Cresemba
isavuconazole, Aspergillosis
Date of authorisation: 15/10/2015,, Revision: 9, Authorised, Last updated: 26/08/2020
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): Vivanza
vardenafil, Erectile Dysfunction
Date of authorisation: 04/03/2003, Revision: 27, Authorised, Last updated: 22/04/2020with some medicines, such as ketoconazole and itraconazole (to treat … with some medicines, such as ketoconazole and itraconazole (to treat … -
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Human medicine European public assessment report (EPAR): Levitra
vardenafil, Erectile Dysfunction
Date of authorisation: 06/03/2003, Revision: 31, Authorised, Last updated: 22/04/2020Levitra must not be taken with ketoconazole and itraconazole (used to … Levitra must not be taken with ketoconazole and itraconazole (used to … -
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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: 28/11/2019include medicines such as ketoconazole and itraconazole (used to … include medicines such as ketoconazole and itraconazole (used …