93 results
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Human medicine European public assessment report (EPAR): Voriconazole Hikma (previously Voriconazole Hospira)
voriconazole, Bacterial Infections and Mycoses; Aspergillosis; Candidiasis
Date of authorisation: 27/05/2015,
, Revision: 12, Authorised, Last updated: 16/06/2023
Voriconazole Hikma (previously Voriconazole … report (EPAR) for Voriconazole Hikma. It explains how the Agency … on how to use Voriconazole Hikma. For practical information … -
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Referral: Ciprofloxacin Hikma
ciprofloxacin, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 25/01/2007, EC decision date: 11/06/2007, Last updated: 06/09/2007Ciprofloxacin Hikma … decision Overview Ciprofloxacin Hikma and associated names, 2 mg/ml … Gram-positive organisms. Hikma Farmaceutica Lda. submitted … -
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Press release: European Medicines Agency: Committee for Medicinal Products for Human Use 24-27 July 2006
CHMP, Last updated: 28/07/2006Ciprofloxacine Hikma 200 mg/100 ml … procedure for Ciprofloxacine Hikma 200 mg/100 ml (ciprofloxacine … ciprofloxacine lactate), from Hikma Farmaceutica, Portugal, because … -
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Human medicine European public assessment report (EPAR): Zoledronic acid Mylan
zoledronic acid, Fractures, Bone
Date of authorisation: 23/08/2012,, Revision: 14, Authorised, Last updated: 20/04/2023
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 March 2015
CHMP, Last updated: 27/03/2015Tamiflu: EPAR Voriconazole Hikma (previously Voriconazole … -
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Referral: Pseudoephedrine-containing medicinal products (updated)
pseudoephedrine, Article 31 referrals
Status: Under evaluation, Last updated: 29/09/2023 -
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Referral: Vancomycin-containing medicines
vancomycin, Article 31 referrals
Status: European Commission final decision, opinion/position date: 18/05/2017, EC decision date: 21/09/2017, Last updated: 17/11/2017 -
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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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Referral: Medicinal products containing lactose of bovine origin for IV/IM use in acute allergic reactions
methylprednisolone, Article 31 referrals
Status: CMDh final position, opinion/position date: 31/07/2017, Last updated: 04/09/2017 -
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Referral: Bisphosphonates
alendronic acid, clodronic acid, etidronic acid, ibandronic acid, neridronic acid, pamidronic acid, risedronic acid, tiludronic acid, zoledronic acid, associated names: Actonel, Aredia, Bonefos, Didronel, Fosamax, Nerixia, Skelid, Article 31 referrals
Status: European Commission final decision, opinion/position date: 14/04/2011, EC decision date: 13/07/2011, Last updated: 28/10/2011 -
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Orphan designation: Enzastaurin hydrochloride for: Treatment of diffuse large B-cell lymphoma (updated)
Date of designation: 20/03/2007, Withdrawn, Last updated: 12/09/2023kezelése Italian Enzastaurina cloridrato Terapia del Linfoma non-Hodgkin … -
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Referral: Diclofenac-containing medicines
diclofenac, Article 31 referrals
Status: European Commission final decision, opinion/position date: 26/06/2013, EC decision date: 25/09/2013, Last updated: 27/11/2013 -
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Orphan designation: N-(5-tert-Butylisoxazol-3-yl)-N'-{4-[7-(2-(morpholin-4-yl)ethoxy) imidazo[2,1-b][1,3]benzothiazol-2-yl]phenyl}urea di-hydrochloride salt for: Treatment of acute myeloid leukaemia (updated)
Date of designation: 23/03/2009, Positive, Last updated: 15/09/2023 -
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Referral: Serotonin-specific reuptake inhibitors and serotonin-noradrenaline reuptake inhibitors
atomoxetine, citalopram, escitalopram, fluoxetine, fluvoxamine, mianserine, milnacipran, mirtazapine, paroxetine, reboxetine, sertraline, venlafaxine, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/04/2005, EC decision date: 19/08/2005, Last updated: 03/11/2005 -
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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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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: (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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Orphan designation: Ponatinib hydrochloride for: Treatment of gastrointestinal stromal tumours
Date of designation: 15/01/2015, Withdrawn, Last updated: 18/03/2022 -
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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 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: (R-S) baclofen, naltrexone hydrochloride, D-sorbitol for: Treatment of Charcot-Marie-Tooth disease type 1A
Date of designation: 26/03/2014, Positive, Last updated: 16/07/2021