65 results
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Referral: Sandimmun Neoral and associated names
ciclosporin, Article 30 referrals
Status: European Commission final decision, opinion/position date: 27/06/2013, EC decision date: 31/10/2013, Last updated: 20/12/2013Sandimmun Neoral and associated names … Agency completed a review of Sandimmun and Sandimmun Neoral. The Agency's Committee for … prescribing information for Sandimmun and … -
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Referral: Sandimmun and associated names
ciclosporin, Article 30 referrals
Status: European Commission final decision, opinion/position date: 27/06/2013, EC decision date: 31/10/2013, Last updated: 20/12/2013Sandimmun and associated names … Agency completed a review of Sandimmun and Sandimmun Neoral. The Agency's Committee for … prescribing information for Sandimmun and … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 June 2013
CHMP, Last updated: 28/06/2013Sandimmun Sandimmun Neoral INN ciclosporin Marketing-authorisation … -
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Referral: Ciclosporin IDL
ciclosporin, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 18/03/2010, EC decision date: 22/07/2010, Last updated: 20/11/2013medicine authorised in Germany (Sandimmun Optoral 25 mg capsules … medicine authorised in Germany (Sandimmun Optoral 25 mg capsules … medicine authorised in Germany (Sandimmun Optoral 25 mg capsules … -
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National expert: Raffaella Sardelli, Italian Medicines Agency (updated)
- Declaration of interests - 39.64 KB | PDF
- Curriculum Vitae - 31.8 KB | PDF
“Contaminazione da alluminio in soluzioni di albumina umana: un monitoraggio … dell’attivatore della precallicreina in soluzioni di albumina umana” (Abs … -
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National expert: Eraldo Donnarumma, Italian Medicines Agency (updated)
- Declaration of interests - 39.3 KB | PDF
- Curriculum Vitae - 25.83 KB | PDF
PANORAMI E PERCORSI) “Doping: soluzione o inganno chimico? (BIF n.4/2006 … -
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Human medicine European public assessment report (EPAR): Simulect
basiliximab, Graft Rejection; Kidney Transplantation
Date of authorisation: 09/10/1998, Revision: 27, Authorised, Last updated: 20/04/2023 -
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Human medicine European public assessment report (EPAR): Advagraf
tacrolimus, Graft Rejection
Date of authorisation: 23/04/2007, Revision: 25, Authorised, Last updated: 15/11/2022 -
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Human medicine European public assessment report (EPAR): Kinpeygo
budesonide, micronised, Glomerulonephritis, IGA
Date of authorisation: 15/07/2022,
, 
, 
, Revision: 2, Authorised, Last updated: 23/11/2022
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Human medicine European public assessment report (EPAR): Lupkynis
Voclosporin, Lupus Nephritis
Date of authorisation: 15/09/2022,, Revision: 1, Authorised, Last updated: 07/02/2023
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Human medicine European public assessment report (EPAR): Modigraf
tacrolimus, Graft Rejection
Date of authorisation: 15/05/2009, Revision: 18, Authorised, Last updated: 15/11/2022 -
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Human medicine European public assessment report (EPAR): Cholestagel
colesevelam (as hydrochloride), Hypercholesterolemia
Date of authorisation: 09/03/2004, Revision: 23, Authorised, Last updated: 25/05/2021 -
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Human medicine European public assessment report (EPAR): Gilenya (updated)
fingolimod hydrochloride , Multiple Sclerosis
Date of authorisation: 17/03/2011, Revision: 35, Authorised, Last updated: 01/06/2023 -
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Human medicine European public assessment report (EPAR): Sovaldi
Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 16/01/2014,
, Revision: 27, Authorised, Last updated: 09/02/2023
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Human medicine European public assessment report (EPAR): Xeljanz
Tofacitinib, Arthritis, Rheumatoid
Date of authorisation: 22/03/2017,
Date of refusal: 25/04/2013,
, Revision: 26, Authorised, Last updated: 30/03/2023
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Human medicine European public assessment report (EPAR): Rapamune
Sirolimus, Graft Rejection; Kidney Transplantation
Date of authorisation: 13/03/2001, Revision: 46, Authorised, Last updated: 25/07/2022 -
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Human medicine European public assessment report (EPAR): Heparesc
Human heterologous liver cells, Urea Cycle Disorders, Inborn
Date of refusal: 21/12/2015,, Refused, Last updated: 04/04/2016
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National expert: Armando Magrelli, Italian Medicines Agency (updated)
- Declaration of interests - 39.3 KB | PDF
- Curriculum Vitae - 50.53 KB | PDF
Country: Italy Employer: Con Soluzioni Con Srl • Start date: 042004 • … -
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Human medicine European public assessment report (EPAR): Riprazo
aliskiren, Hypertension
Date of authorisation: 22/08/2007, Revision: 8, Withdrawn, Last updated: 01/03/2013 -
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Human medicine European public assessment report (EPAR): Riprazo HCT
aliskiren, hydrochlorothiazide, Hypertension
Date of authorisation: 13/04/2011, Withdrawn, Last updated: 20/09/2012 -
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Human medicine European public assessment report (EPAR): Sprimeo
aliskiren, Hypertension
Date of authorisation: 22/08/2007, Revision: 5, Withdrawn, Last updated: 23/07/2012 -
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Human medicine European public assessment report (EPAR): Afinitor
everolimus, Carcinoma, Renal Cell; Breast Neoplasms; Pancreatic Neoplasms
Date of authorisation: 02/08/2009, Revision: 30, Authorised, Last updated: 27/06/2022 -
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Human medicine European public assessment report (EPAR): Rasilamlo
aliskiren, amlodipine, Hypertension
Date of authorisation: 14/04/2011, Revision: 7, Withdrawn, Last updated: 28/03/2017 -
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Human medicine European public assessment report (EPAR): Victrelis
Boceprevir, Hepatitis C, Chronic
Date of authorisation: 18/07/2011, Revision: 22, Withdrawn, Last updated: 31/07/2018 -
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Withdrawn application: Vekacia
ciclosporin, date of withdrawal: 14/11/2008, Initial authorisation, Last updated: 18/11/2008