64 results
Keyword Valganciclovir Remove keyword
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Opinion/decision on a Paediatric investigation plan (PIP): Valganciclovir
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000726-PIP01-09-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Powder for oral solution
Decision date: 06/09/2013, Last updated: 08/10/2013, Compliance check: V, 11/10/2013Valcyte and associated names Valganciclovir Infectious diseasesP/0220/2013EMEA-000726-PIP01-09-M02 … paediatric investigation plan for valganciclovir (Valcyte and associated names … paediatric investigation plan for valganciclovir (Valcyte and associated … -
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Orphan designation: Brincidofovir for: Prevention of cytomegalovirus disease
Date of designation: 28/04/2016, Positive, Last updated: 23/05/2019ganciclovir, valaciclovir and valganciclovir). The sponsor has provided … ganciclovir, valaciclovir and valganciclovir). The sponsor has provided … -
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Orphan designation: Letermovir for: Treatment of cytomegalovirus disease in patients with impaired cell-mediated immunity
Date of designation: 06/06/2012, Positive, Last updated: 28/06/2018cell-mediated immunity (ganciclovir, valganciclovir, valaciclovir, foscarnet and … mediated immunity (ganciclovir, valganciclovir, valaciclovir, foscarnet … -
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Orphan designation: allogenic cytomegalovirus-specific cytotoxic T lymphocytes for: Treatment of cytomegalovirus infection in patients with impaired cell-mediated immunity
Date of designation: 18/11/2016, Positive, Last updated: 13/12/2016ganciclovir, valaciclovir and valganciclovir). The sponsor has provided … ganciclovir, valaciclovir and valganciclovir). The sponsor has provided … -
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Orphan designation: Allogeneic CD4+ and CD8+ T lymphocytes ex vivo incubated with synthetic peptides of the viral antigens of cytomegalovirus, adenovirus and Epstein-Barr virus for: Treatment of cytomegalovirus infection following haematopoietic stem cell transplantation
Date of designation: 12/02/2015, Positive, Last updated: 09/04/2015ganciclovir, valaciclovir and valganciclovir). The sponsor has provided … ganciclovir, valaciclovir and valganciclovir). The sponsor has provided … -
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Press release: European Medicines Agency finalises review of medicines concerned by Roche pharmacovigilance inspection
Last updated: 19/11/2013trimethoprim/sulfamethoxazole, and valganciclovir. List item … trimethoprim/sulfamethoxazole, and valganciclovir 4. More information on … -
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Orphan designation: Covalently closed DNA plasmids coding for cytomegalovirus phosphoprotein 65 and glycoprotein B genes for: Prevention of cytomegalovirus disease in patients with impaired cell-mediated immunity
Date of designation: 09/08/2012, Withdrawn, Last updated: 21/02/2019ganciclovir, valaciclovir and valganciclovir) were approved in the EU for … -
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Referral: Cymevene
ganciclovir, associated names: Cymevan, Citovirax, Article 30 referrals
Status: European Commission final decision, opinion/position date: 25/02/2016, EC decision date: 28/04/2016, Last updated: 21/06/2016related antiviral medicine, valganciclovir, or to any other ingredients … related antiviral medicine, valganciclovir, or to any other ingredients … -
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Orphan designation: Maribavir for: Treatment of cytomegalovirus disease in patients with impaired cell-mediated immunity
Date of designation: 07/06/2013, Positive, Last updated: 17/09/2021ganciclovir, valaciclovir and valganciclovir). The sponsor has provided … ganciclovir, valaciclovir and valganciclovir). The sponsor has provided … -
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National expert: Wei Zhao, European Medicines Agency (updated)
- Declaration of interests - 79.87 KB | PDF
- Curriculum Vitae - 34.35 KB | PDF
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National expert: Rafael de la Camara, Spanish Agency of Medicines and Medical Devices (updated)
- Declaration of interests - 85.67 KB | PDF
- Curriculum Vitae - 53.03 KB | PDF
PATIENTS 11/2011-09/2012 ROCHE VALGANCICLOVIR CMV MANAGEMENT IN SCT PATIENTS … -
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Orphan designation: (S)-{8-Fluoro-2-2[4-(3-methoxyphenyl)-1-piperazinyl]-3-[2-methoxy-5-(trifluoromethyl)-phenyl]-3, 4-dihydro-4-quinazolinyl} acetic acid (letermovir) for: Prevention of cytomegalovirus disease in patients with impaired cell-mediated immunity
Date of designation: 15/04/2011, Positive, Last updated: 28/06/2018deemed at risk (ganciclovir, valganciclovir and valaciclovir). Patients … deemed at risk (ganciclovir, valganciclovir and valaciclovir). Patients … -
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National expert: Emile F. Schippers, European Medicines Agency (updated)
- Declaration of interests - 79.84 KB | PDF
- Curriculum Vitae - 33.36 KB | PDF
of cytomegalovirus DNA load by oral valganciclovir and intravenous ganciclovir … -
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Human medicine European public assessment report (EPAR): Mycophenolate mofetil Teva (updated)
mycophenolate mofetil, Graft Rejection
Date of authorisation: 21/02/2008,
, Revision: 25, Authorised, Last updated: 24/06/2022
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Human medicine European public assessment report (EPAR): Myfenax (updated)
mycophenolate mofetil, Graft Rejection
Date of authorisation: 21/02/2008,, Revision: 26, Authorised, Last updated: 23/06/2022
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Human medicine European public assessment report (EPAR): Prevymis
Letermovir, Cytomegalovirus Infections
Date of authorisation: 08/01/2018,
, 
, Revision: 10, Authorised, Last updated: 10/01/2022
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Human medicine European public assessment report (EPAR): CellCept
mycophenolate mofetil, Graft Rejection
Date of authorisation: 14/02/1996, Revision: 37, Authorised, Last updated: 02/03/2022 -
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Human medicine European public assessment report (EPAR): Myclausen
mycophenolate mofetil, Graft Rejection
Date of authorisation: 07/10/2010,, Revision: 14, Authorised, Last updated: 03/03/2022
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Human medicine European public assessment report (EPAR): Ivozall
clofarabine, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 14/11/2019,, Revision: 3, Authorised, Last updated: 24/11/2021
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Human medicine European public assessment report (EPAR): Delstrigo
doravirine, lamivudine, tenofovir disoproxil fumarate, HIV Infections
Date of authorisation: 22/11/2018,, Revision: 7, Authorised, Last updated: 12/04/2022
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Human medicine European public assessment report (EPAR): Evoltra
clofarabine, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 29/05/2006,, 
, Revision: 30, Authorised, Last updated: 04/05/2021
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Human medicine European public assessment report (EPAR): Zutectra
human hepatitis B immunoglobulin, Immunization, Passive; Hepatitis B; Liver Transplantation
Date of authorisation: 30/11/2009, Revision: 14, Authorised, Last updated: 04/03/2022 -
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Human medicine European public assessment report (EPAR): Vemlidy
tenofovir alafenamide fumarate, Hepatitis B
Date of authorisation: 09/01/2017, Revision: 13, Authorised, Last updated: 12/01/2022 -
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Human medicine European public assessment report (EPAR): Vfend
voriconazole, Candidiasis; Mycoses; Aspergillosis
Date of authorisation: 19/03/2002, Revision: 51, Authorised, Last updated: 06/05/2022 -
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Human medicine European public assessment report (EPAR): Nulojix
belatacept, Graft Rejection; Kidney Transplantation
Date of authorisation: 17/06/2011, Revision: 18, Authorised, Last updated: 20/04/2022