364 results
Keyword Ganciclovir Medac Remove keyword
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Human medicine European public assessment report (EPAR): Vitrasert Implant
ganciclovir, Cytomegalovirus Retinitis; HIV Infections
Date of authorisation: 18/03/1997, Withdrawn, Last updated: 13/05/2002ganciclovir … Statement Vitrasert Implant (Ganciclovir) The European Agency … STATEMENT ON VITRASERT IMPLANT (Ganciclovir) WITHDRAWAL OF THE MARKETING … -
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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: 21/06/2016contains the active substance ganciclovir and is available as a powder … Cymevene IV, INN: ganciclovir 30 Churchill Place … Cymevene and associated names (ganciclovir, 500 mg powder for concentrate … -
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Human medicine European public assessment report (EPAR): Leflunomide medac (updated)
leflunomide, Arthritis, Rheumatoid
Date of authorisation: 27/07/2010,
, Revision: 18, Authorised, Last updated: 09/03/2023
Leflunomide medac Musculoskeletal Diseases Joint … report (EPAR) for Leflunomide medac. It explains how the The committee … conditions of use for Leflunomide medac. What is Leflunomide medac? Leflunomide medac is a medicine that contains … -
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Human medicine European public assessment report (EPAR): Pemetrexed medac
pemetrexed, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 26/11/2015,, Revision: 8, Authorised, Last updated: 09/08/2022
Pemetrexed medac Cancer Neoplasms Carcinoma … Pemetrexed medac … Pemetrexed medac, INN-pemetrexed 30 … -
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Human medicine European public assessment report (EPAR): Capecitabine Medac
capecitabine, Colorectal Neoplasms
Date of authorisation: 19/11/2012,, Revision: 12, Authorised, Last updated: 25/04/2022
Capecitabine Medac Cancer Neoplasms Intestinal … Capecitabine Medac … EU/1/12/802/001 Capecitabine medac 150 mg … -
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Human medicine European public assessment report (EPAR): Imatinib medac
imatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Dermatofibrosarcoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Myelodysplastic-Myeloproliferative Diseases; Hypereosinophilic Syndrome
Date of authorisation: 25/09/2013,, Revision: 5, Withdrawn, Last updated: 16/10/2019
Imatinib medac Precursor Cell Lymphoblastic … authorisation for Imatinib Medac has been withdrawn at the … Summary documents Imatinib medac : EPAR - Summary for the … -
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Human medicine European public assessment report (EPAR): Arsenic trioxide medac
Arsenic trioxide, Leukemia, Promyelocytic, Acute
Date of authorisation: 17/09/2020,, Revision: 2, Authorised, Last updated: 26/04/2022
Arsenic trioxide medac Cancer Neoplasms Leukemia … Arsenic trioxide medac … PRODUCT Arsenic trioxide medac 1 mg/ml concentrate for solution … -
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Human medicine European public assessment report (EPAR): Zoledronic acid medac
zoledronic acid monohydrate, Fractures, Bone; Cancer
Date of authorisation: 03/08/2012,, Revision: 13, Authorised, Last updated: 20/11/2020
Zoledronic acid medac Wounds and Injuries Cancer Neoplasms Fractures … Zoledronic acid medac … Zolderonic acid medac, INN-zoledronic acid … -
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Referral: Fluorouracil and fluorouracil related substances (capecitabine, tegafur and flucytosine) containing medicinal products
capecitabine, fluorouracil, tegafur, flucytosine, associated names: Xeloda, Teysuno, Capecitabine Accord, Capecitabine Medac, Capecitabine Teva, Ecansya (previously Capecitabine Krka), Article 31 referrals
Status: European Commission final decision, opinion/position date: 30/04/2020, EC decision date: 07/07/2020, Last updated: 23/07/2020itabine Accord Capecitabine Medac Capecitabine Teva Ecansya … Krka) Xeloda Teysuno Capecitabine Accord Capecitabine Medac Capecitabine Teva Ecansya … -
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Direct healthcare professional communication (DHPC): 5-Fluorouracil (i.v.), capecitabine and tegafur containing products: Pre-treatment testing to identify DPD-deficient patients at increased risk of severe toxicity
Active substance: Fluorouracil, capecitabine, tegafur, DHPC type: Referral - Article 31, Last updated: 04/06/2020Capecitabine Accord Capecitabine Medac Capecitabine Teva Ecansya … itabine Accord Capecitabine Medac Capecitabine Teva Ecansya … Krka) Teysuno Xeloda Capecitabine Accord Capecitabine Medac Capecitabine Teva Ecansya … -
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Human medicine European public assessment report (EPAR): Livtencity (updated)
Maribavir, Cytomegalovirus Infections
Date of authorisation: 09/11/2022,
, 
, Revision: 3, Authorised, Last updated: 17/03/2023
other treatment, including ganciclovir, valganciclovir, cidofovir … not be used together with ganciclovir or valganciclovir (other … other treatment, including ganciclovir, valganciclovir, cidofovir … -
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Orphan designation: Adenovirus-mediated herpes-simplex-virus thymidine-kinase (HKSV-tk) gene for: Treatment of high-grade glioma with subsequent use of ganciclovir sodium
Date of designation: 06/02/2002, Positive, Last updated: 16/09/2021glioma with subsequent use of ganciclovir sodium. A marketing authorisation … administration of the drug ganciclovir, which is a prodrug (a drug … cells is able to metabolise ganciclovir transforming it into a drug … -
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Orphan designation: Nanatinostat, Valganciclovir for: Treatment of peripheral T-cell lymphoma
Date of designation: 10/08/2022, Positive, Last updated: 15/12/2022by the antiviral medicine ganciclovir. The medicine contains 2 The … of the antiviral medicine ganciclovir. The administration of nanatinostat … trigger the activation of ganciclovir. The activated form of … -
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Human medicine European public assessment report (EPAR): Trecondi
Treosulfan, Hematopoietic Stem Cell Transplantation
Date of authorisation: 20/06/2019,, Revision: 3, Authorised, Last updated: 25/01/2023
Marketing-authorisation holder medac Gesellschaft für klinische … -
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Summary of opinion: Trecondi
treosulfan, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023action. medicinal product is medac Gesellschaft für klinische … this medicinal product is medac Gesellschaft für klinische … -
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Press release: New cell-based therapy to support stem cell transplantation in patients with high-risk blood cancer
CHMP, Last updated: 24/06/2016susceptible to a medicine called ganciclovir. If the patient develops graft-versus-host … graft-versus-host disease, ganciclovir is given, which kills the … Nine of those were given ganciclovir and none of them died or … -
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Human medicine European public assessment report (EPAR): Temomedac
temozolomide, Glioma; Glioblastoma
Date of authorisation: 25/01/2010,, Revision: 15, Authorised, Last updated: 28/03/2022
Marketing-authorisation holder medac Gesellschaft für klinische … -
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Orphan designation: Brincidofovir for: Prevention of cytomegalovirus disease
Date of designation: 28/04/2016, Positive, Last updated: 23/05/2019cytomegalovirus immunoglobulin, ganciclovir, valaciclovir and valganciclovir … cytomegalovirus immunoglobulin, ganciclovir, valaciclovir and valganciclovir … -
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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: 09/04/2015systems (cidofovir, foscarnet, ganciclovir, valaciclovir and valganciclovir … systems (cidofovir, foscarnet, ganciclovir, valaciclovir and valganciclovir … -
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Orphan designation: Treosulfan for: Conditioning treatment prior to haematopoietic-progenitor-cell transplantation
Date of designation: 22/02/2004, Positive, Last updated: 11/12/2020the European Commission to medac Gesellschaft fuer klinische … the European Commission to medac Gesellschaft fuer klinische … Sponsor’s contact details: medac Gesellschaft für klinische … -
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Opinion/decision on a Paediatric investigation plan (PIP): Trecondi, Treosulfan (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation; Oncology
PIP number: EMEA-000883-PIP01-10-M05, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution
Decision date: 09/09/2020, Last updated: 10/03/2023, Compliance check: V, 25/03/2022transplantation Intravenous use medac Gesellschaft für klinische … 0) 401380060 E-mail: dra@medac.de PM: decision on the application … application submitted by medac Gesellschaft für klinische … -
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Human medicine European public assessment report (EPAR): Spectrila
asparaginase, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 14/01/2016, Revision: 5, Authorised, Last updated: 09/10/2020Marketing-authorisation holder Medac Gesellschaft fuer klinische … -
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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: 24/11/2022immunity (cidofovir, foscarnet, ganciclovir, valaciclovir and valganciclovir … immunity (cidofovir, foscarnet, ganciclovir, valaciclovir and valganciclovir … -
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Human medicine European public assessment report (EPAR): Gliolan
5-aminolevulinic acid hydrochloride, Glioma
Date of authorisation: 07/09/2007, Revision: 7, Authorised, Last updated: 10/08/2022European Union for Gliolan to Medac Gesellschaft für klinische … -
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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: 21/02/2019antiviral medicines (aciclovir, ganciclovir, valaciclovir and valganciclovir …