107 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 AHCL
posaconazole, Mycoses
Date of authorisation: 25/07/2019,
, Revision: 5, Authorised, Last updated: 22/12/2022
authorised in the EU called Noxafil. Expand section Collapse section … 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 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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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: Procaine benzylpenicillin
Article 82
Status: Procedure started, opinion/position date: 18/02/2022, Last updated: 20/07/2023 -
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Referral: Modified live porcine respiratory and reproductive syndrome (PRRS) virus vaccines
Porcine respiratory and reproductive syndrome virus vaccine (live), associated names: See annex I, Article 35
Status: European Commission final decision, opinion/position date: 15/04/2021, EC decision date: 13/07/2021, Last updated: 28/07/2021 -
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Referral: Valbazen 100 mg/ml Total Spectrum Wormer oral suspension and associated names, including its generic/hybrid products
albendazole, Article 35
Status: European Commission final decision, opinion/position date: 05/11/2020, EC decision date: 18/01/2021, Last updated: 22/02/2021Italy Valbazen 100 mg/ml sospensione per uso orale per bovini … Sverminator 10, 100 mg/ml, sospensione orale per bovini ed ovini … Albex Gold 200 mg/ml sospensione orale per bovini Albendazole … -
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Referral: Florgane
florfenicol, Article 33
Status: European Commission final decision, opinion/position date: 06/03/2013, EC decision date: 23/05/2013, Last updated: 10/07/2013Belgium Florgane 300 mg/ml sospensione iniettabile per bovini e … -
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Referral: Cevazuril
toltrazuril, Article 33
Status: European Commission final decision, opinion/position date: 09/12/2009, EC decision date: 26/03/2010, Last updated: 05/05/2010FRANCE CEVAZURIL 50 mg/ml, sospensione orale per suinetti Oral … -
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Referral: Terfenadine
terfenadine, Article 31 referrals
Status: European Commission final decision, opinion/position date: 20/11/1997, EC decision date: 22/09/1998, Last updated: 22/01/1998 -
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Orphan designation: Mercaptopurine for: Treatment of acute lymphoblastic leukaemia
Date of designation: 30/04/2009, Expired, Last updated: 05/05/2022 -
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Orphan designation: Beta-artemether, lumefantrine for: Treatment of malaria
Date of designation: 28/01/2010, Positive, Last updated: 25/02/2010 -
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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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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10 - 12 May 2023
PRAC, Last updated: 22/05/2023 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 25/09/2023 -
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CHMP: Agendas, minutes and highlights (updated)
Last updated: 11/09/2023 -
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Exemptions to labelling and package-leaflet obligations
Last updated: 19/04/2023