108 results
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Opinion/decision on a Paediatric investigation plan (PIP): Noxafil, posaconazole
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000468-PIP02-12-M07, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Oral suspension, Gastro-resistant tablet, Gastro-resistant powder for oral suspension, Concentrate for solution for infusion
Decision date: 09/06/2022, Last updated: 27/06/2023, Compliance check: XInvented name Noxafil Active substance posaconazole … plan for posaconazole (Noxafil), (EMEA-000468-PIP02-12-M07 … investigation plan for posaconazole (Noxafil), (EMEA-000468-PIP02-12-M07 … -
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Human medicine European public assessment report (EPAR): Noxafil
posaconazole, Candidiasis; Mycoses; Coccidioidomycosis; Aspergillosis
Date of authorisation: 25/10/2005, Revision: 37, Authorised, Last updated: 20/06/2023Noxafil Infections Bacterial Infections … orised posaconazole Overview Noxafil is an antifungal medicine … EMA warns that Noxafil tablets and oral suspension … -
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News: EMA warns that Noxafil tablets and oral suspension have different doses and are not interchangeable
Last updated: 24/06/2016EMA warns that Noxafil tablets and oral suspension … Product information for Noxafil (posaconazole) is to be updated … interchanged at the same dose. Noxafil, a medicine for serious fungal … -
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Human medicine European public assessment report (EPAR): Posaconazole Accord
posaconazole, Mycoses
Date of authorisation: 25/07/2019,
, Revision: 7, Authorised, Last updated: 19/12/2022
authorised in the EU called Noxafil. For more information on generic … with the reference medicine, Noxafil, and do not need to be repeated … and to be bioequivalent to Noxafil. Therefore, the Agency’s … -
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Human medicine European public assessment report (EPAR): Posaconazole AHCL (updated)
posaconazole, Mycoses
Date of authorisation: 25/07/2019,, Revision: 6, Authorised, Last updated: 20/11/2023
authorised in the EU called Noxafil. How is Posaconazole AHCL … with the reference medicine, Noxafil, and do not need to be repeated … and to be bioequivalent to Noxafil. Therefore, the Agency’s … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 September 2021
CHMP, Last updated: 17/09/2021Noxafil … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 8-11 November 2021
CHMP, Last updated: 12/11/2021Noxafil … -
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use, 18-21 September 2006
CHMP, Last updated: 21/09/2006Noxafil … treatment of type-2 diabetes. Noxafil (posaconazole) and Posaconazole … oropharyngeal candidiasis in adults. Noxafil and Posaconazole SP were … -
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National expert: Hugues Malonne, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 41.98 KB | PDF
- Curriculum Vitae - 46.94 KB | PDF
Isentress _ Keytruda _ Noxafil Diabetes (type 2) _ HIV … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 June 2016
CHMP, Last updated: 24/06/2016requirements'. product information for Noxafil … -
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Human medicine European public assessment report (EPAR): Posaconazole SP
posaconazole, Candidiasis; Mycoses; Coccidioidomycosis; Aspergillosis
Date of authorisation: 25/10/2005, Revision: 5, Withdrawn, Last updated: 04/08/2009SP is no longer valid. Noxafil (posaconazole) is an identical … -
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Recommendations on medication errors
Last updated: 24/06/2020 -
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Referral: Didanosine
didanosine, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 19/09/2013, EC decision date: 20/11/2013, Last updated: 10/12/2013Aurobindo 200mg capsule rigide gastroresistenti 200 mg Gastro-resistant … Aurobindo 250mg capsule rigide gastroresistenti 250 mg Gastro-resistant … Aurobindo 400mg capsule rigide gastroresistenti 400 mg Gastro-resistant … -
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Referral: Lansoprazol-ratiopharm 15 mg and 30 mg
Lansoprazole, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 15/09/2005, EC decision date: 21/02/2006, Last updated: 25/02/2006 -
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Referral: GVK Biosciences
esomeprazole magnesium, candesartan cilexetil, nebivolol, desloratadine, donepezil, repaglinide, candesartan, esomeprazole, alendronic acid, ropinirole, cefpodoxime, quetiapine, trimetazidine, bosentan, tramadol, paracetamol, escitalopram, trimetazidine hydrochloride, entacapone, valsartan, hydrochlorothiazide, donepezil hydrochloride, ropinirole hydrochloride, clopidogrel hydrochloride, escitalopram oxalate, metformin hydrochloride, trimetazidine dihydrochloride, rizatriptan benzoate, metformin, fluconazole, eletriptan, rizatriptan, ebastine, ibuprofen, desmopressin, aciclovir, levetiracetam, irbesartan, venlafaxine, ciprofloxacin, cefpodoxime proxetil, tacrolimus, fexofenadine hydrochloride, phenoxymethylpenicillin, amlodipine besilate, metoclopramide, clopidogrel, levodopa, carbidopa, entacapone, atorvastatin, telmisartan, clindamycin hydrochloride, metoclopramide hydrochloride, clonazepam, clobazam, dexamethasone, thiamine hydrochloride, tramadol hydrochloride, pioglitazone, dipyridamole, fexofenadine, amlodipine, pantoprazole, hydrocortisone, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/05/2015, EC decision date: 16/07/2015, Last updated: 04/08/2015 -
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Orphan designation: Cysteamine bitartrate (gastroresistant) (mercaptamine) for: Treatment of cystinosis
Date of designation: 20/09/2010, Positive, Last updated: 10/10/2013 -
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Orphan designation: hydrocortisone for: Treatment of adrenal insufficiency
Date of designation: 22/05/2006, Expired, Last updated: 25/11/2021 -
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Orphan designation: hydrocortisone for: Treatment of congenital adrenal hyperplasia
Date of designation: 27/07/2005, Positive, Last updated: 14/06/2021 -
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Orphan designation: dexamethasone for: Treatment of multiple myeloma
Date of designation: 09/06/2010, Withdrawn, Last updated: 12/02/2018kezelése Italian Desametasone (compressa da 40 mg) Trattamento del … -
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Outcomes of imposed non-interventional post-authorisation safety studies (updated)
Last updated: 30/11/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 10-12 May 2023
European Medicines Agency, Amsterdam, the Netherlands, from 10/05/2023 to 12/05/2023, Last updated: 31/08/2023 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 30/11/2023 -
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CHMP: Agendas, minutes and highlights (updated)
Last updated: 10/11/2023 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10 - 12 May 2023
PRAC, Last updated: 22/05/2023 -
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Sampling and testing (updated)
Last updated: 07/11/2023