27 results
Keyword Droperidolo Hikma Remove keyword
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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: 11, Authorised, Last updated: 25/04/2022
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: 12/05/2023 -
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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: 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: 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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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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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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Pharmacovigilance Risk Assessment Committee (PRAC): 24-27 October 2022
European Medicines Agency, Amsterdam, the Netherlands, from 24/10/2022 to 27/10/2022, Last updated: 31/03/2023 -
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Public data from Article 57 database
Last updated: 17/10/2022 -
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Committee for Medicinal Products for Human Use (CHMP): 27-30 March 2023 (updated)
European Medicines Agency, Amsterdam, the Netherlands, from 27/03/2023 to 30/03/2023, Last updated: 22/05/2023 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 07/06/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 13-16 March 2023
European Medicines Agency, Amsterdam, the Netherlands, from 13/03/2023 to 16/03/2023, Last updated: 18/08/2021 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13 - 16 March 2023
PRAC, Last updated: 17/03/2023 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 24 - 27 October 2022
PRAC, Last updated: 28/10/2022 -
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use,22-24 January 2007
CHMP, Last updated: 25/01/2007For Ciprofloxacin Nycomed Hikma 200 mg/100 ml solution for … ciprofloxacine lactate), from Hikma Farmaceutica (Portugal) LDA … -
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Stability testing for applications for variations to marketing authorisation - Scientific guideline
Last updated: 09/04/2014 -
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EudraVigilance: electronic reporting
Last updated: 15/02/2022 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 31 August-3 September 2020
Virtual meeting, from 31/08/2020 to 03/09/2020, Last updated: 27/02/2018 -
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CHMP: Agendas, minutes and highlights (updated)
Last updated: 06/06/2023 -
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Download medicine data
Last updated: 02/12/2021