19877 results
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Human medicine European public assessment report (EPAR): Breyanzi
CD19-directed genetically modified autologous cell-based product consisting of purified CD8+ T-cells (CD8+ cells), CD19-directed genetically modified autologous cell-based product consisting of purified CD4+ T cells (CD4+ cells), Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular; Mediastinal Neoplasms
Date of authorisation: 04/04/2022,
, Authorised, Last updated: 20/05/2022
Breyanzi is a medicine used to treat adults with … type of advanced therapy medicine called a ‘gene therapy product’. This is a type of medicine that works by delivering … 781 6000 © European Medicines Agency, 2022. Reproduction … -
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Veterinary medicine European public assessment report (EPAR): Ecoporc Shiga
genetically modified recombinant Shiga-toxin-2e antigen, Pigs
Date of authorisation: 10/04/2013, Revision: 4, Authorised, Last updated: 18/09/2020done by the Committee for Medicinal Products for Veterinary Use (CVMP … toxin (Stx2e) that has been modified so that it can no longer … a vaccine containing the modified toxin Stx2e. When Ecoporc … -
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Orphan designation: Genetically modified human adenovirus encoding human PH20 hyaluronidase for: Treatment of pancreatic cancer
Date of designation: 21/06/2011, Positive, Last updated: 31/07/2013Genetically modified human adenovirus encoding … Biosciences S.L., Spain, for genetically modified human adenovirus encoding … the Committee for Orphan Medicinal … -
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Orphan designation: genetically modified replication-incompetent herpes simplex virus-1 expressing collagen VII (beremagene geperpavec) for: Treatment of epidermolysis bullosa
Date of designation: 16/04/2018, Positive, Last updated: 10/11/2022genetically modified replication-incompetent herpes … 2018, A status assigned to a medicine intended for use against … against a rare condition. The medicine must fulfil certain criteria … -
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Orphan designation: Allogeneic retinal pigment epithelial cells genetically modified with a non-viral vector to express human alpha-L-iduronidase for: Treatment of mucopolysaccharidosis type I
Date of designation: 15/10/2021, Withdrawn, Last updated: 20/12/2022for A status assigned to a medicine intended for use against … against a rare condition. The medicine must fulfil certain criteria … designation as an orphan medicine so that it can benefit from … -
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Orphan designation: Autologous haematopoietic cells genetically modified with a lentiviral vector containing the human gp91(phox) gene for: Treatment of X-linked chronic granulomatous disease
Date of designation: 09/02/2012, Positive, Last updated: 14/07/2022ologous haematopoietic cells genetically modified with a lentiviral vector … autologous haematopoietic cells genetically modified with a lentiviral vector … autologous hematopoietic cells genetically modified with a lentiviral vector … -
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Veterinary medicine European public assessment report (EPAR): Medicinal Oxygen Air Liquide Sante
oxygen, Horses; Dogs; Cats
Date of authorisation: 20/12/2006, Withdrawn, Last updated: 21/09/2010Medicinal Oxygen Air Liquide Sante … marketing authorisation for Medicinal Oxygen Air Liquide Santé … holder. Summary documents Medicinal Oxygen Air Liquide Sante … -
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Orphan designation: genetically modified serotype 5/3 adenovirus coding for granulocyte-macrophage colony-stimulating factor for: Treatment of soft tissue sarcoma
Date of designation: 19/06/2013, Positive, Last updated: 19/03/2021genetically modified serotype 5/3 adenovirus coding … Therapeutics Oy, Finland, for genetically modified serotype 5/3 adenovirus coding … the Committee for Orphan Medicinal … -
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Orphan designation: Genetically modified serotype 5/3 adenovirus coding for granulocyte macrophage colony-stimulating factor for: Treatment of malignant mesothelioma
Date of designation: 16/12/2014, Positive, Last updated: 19/03/2021Genetically modified serotype 5/3 adenovirus coding … Therapeutics Oy, Finland, for genetically modified serotype 5/3 adenovirus coding … the Committee for Orphan Medicinal … -
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Orphan designation: Genetically modified Lactococcus lactis bacteria containing the human trefoil factor 1 gene for: Prevention of oral mucositis in head and neck cancer patients undergoing radiation therapy
Date of designation: 27/09/2011, Positive, Last updated: 29/03/2016Genetically modified Lactococcus lactis bacteria … ActoGeniX N.V., Belgium, for genetically modified Lactococcus lactis bacteria … the Committee for Orphan Medicinal … -
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Orphan designation: Autologous dermal fibroblasts genetically modified ex vivo with a lentiviral vector containing the human COL7A1 gene for: Treatment of epidermolysis bullosa
Date of designation: 28/04/2016, Positive, Last updated: 30/05/2016Autologous dermal fibroblasts genetically modified ex vivo with a lentiviral … autologous dermal fibroblasts genetically modified ex vivo with a lentiviral … www.ema.europa.eu/contact © European Medicines Agency, 2016. Reproduction … -
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Opinion/decision on a Paediatric investigation plan (PIP): Allogeneic human neural stem cells genetically modified to express c-MycERTAM, a c-Myc and modified oestrogen receptor fusion protein (CTX0E03)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Neurology
PIP number: EMEA-001969-PIP01-16, Route(s) of administration: Intracerebral use, Pharmaceutical form(s): Suspension for injection
Decision date: 12/09/2016, Last updated: 27/10/2016, Compliance check: XAllogeneic human neural stem cells genetically modified to express c-MycERTAM, a … express c-MycERTAM, a c-Myc and modified oestrogen receptor fusion … 2016 on the granting of a product specific waiver for allogeneic … -
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Opinion/decision on a Paediatric investigation plan (PIP): genetically modified replication-incompetent herpes simplex virus-1 expressing collagen VII (beremagene geperpavec)
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Dermatology
PIP number: EMEA-002472-PIP02-19, Route(s) of administration: Topical use, Pharmaceutical form(s): Gel
Decision date: 08/07/2019, Last updated: 13/11/2019, Compliance check: XActive substance genetically modified replication-incompetent herpes … genetically modified replication-incompetent herpes … -
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Human medicine European public assessment report (EPAR): Zalmoxis
Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2), Hematopoietic Stem Cell Transplantation; Graft vs Host Disease
Date of authorisation: 18/08/2016,
, Revision: 1, Withdrawn, Last updated: 14/02/2020
Product details Name Zalmoxis Agency product number EMEA/H/C/002801 Active … substance Allogeneic T cells genetically modified with a retroviral vector … Zalmoxis allogeneic T cells genetically modified with a retroviral vector … -
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Orphan designation: Allogeneic retinal pigment epithelial cells genetically modified with a non-viral vector to express beta-domain deleted human factor VIII for: Treatment of haemophilia A
Date of designation: 09/12/2020, Withdrawn, Last updated: 05/12/2022pigment epithelial cells genetically modified with a non-viral vector to … 2020, A status assigned to a medicine intended for use against … against a rare condition. The medicine must fulfil certain criteria … -
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Orphan designation: Genetically modified serotype 5/3 adenovirus coding for granulocyte macrophage colony-stimulating factor for the treatment of ovarian cancer for: Treatment of ovarian cancer
Date of designation: 29/04/2014, Positive, Last updated: 19/03/2021Genetically modified serotype 5/3 adenovirus coding … Therapeutics Oy, Finland, for genetically modified serotype 5/3 adenovirus coding … the Committee for Orphan Medicinal … -
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Orphan designation: Genetically modified adeno-associated viral vector serotype 9 expressing shRNA as well as a codon-optimised shRNA-insensitive wildtype PABPN1 for: Treatment of oculopharyngeal muscular dystrophy
Date of designation: 12/01/2017, Positive, Last updated: 11/07/2017Genetically modified adeno-associated viral vector … Clinipace GmbH, Germany, for genetically modified adeno-associated viral vector … the Committee for Orphan Medicinal … -
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Orphan designation: Autologous CD4+ and CD8+ T cells genetically modified with a lentiviral vector encoding a B-cell maturation antigen-specific chimeric antigen receptor for: Treatment of multiple myeloma
Date of designation: 09/12/2020, Withdrawn, Last updated: 26/05/2021logous CD4+ and CD8+ T cells genetically modified with a lentiviral vector … autologous CD4+ and CD8+ T cells genetically modified with a lentiviral vector … 781 6000 © European Medicines Agency, 2021. Reproduction … -
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Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD4+ and CD8+ T cells genetically modified with a lentiviral vector encoding a B cell maturation antigen-specific chimeric antigen receptor (JCARH125)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002909-PIP01-20, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for injection
Decision date: 19/03/2021, Last updated: 09/11/2021, Compliance check: XAutologous CD4+ and CD8+ T cells genetically modified with a lentiviral vector … 2021 on the granting of a product specific waiver for autologous … autologous CD4+ and CD8+ T cells genetically … -
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Orphan designation: Autologous human T cells genetically modified ex-vivo with a lentiviral vector encoding a chimeric antigen receptor for B-cell maturation antigen for: Treatment of multiple myeloma
Date of designation: 28/02/2020, Positive, Last updated: 13/06/2022autologous human T cells genetically modified ex-vivo with a lentiviral … of multiple myeloma. This medicine is now known as ciltacabtagene … ciltacabtagene autoleucel. The medicinal … -
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Orphan designation: Fusion proteins composed by a genetically modified cholera toxin subunit A1, peptides from the acetylcholine receptor alpha chain and a dimer of the D fragment from Staphylococcus aureus protein A for: Treatment of myasthenia gravis
Date of designation: 21/05/2015, Withdrawn, Last updated: 12/04/2019Fusion proteins composed by a genetically modified cholera toxin subunit A1 … fusion proteins composed by a genetically modified cholera toxin subunit A1 … Fusion proteins composed by a genetically modified cholera toxin subunit A1 … -
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Orphan designation: autologous CD34+ hematopoietic stem and progenitor cells genetically modified with the lentiviral vector encoding for the human palmitoyl-protein thioesterase 1 gene for: Treatment of neuronal ceroid lipofuscinosis
Date of designation: 19/07/2021, Positive, Last updated: 16/11/2021for A status assigned to a medicine intended for use against … against a rare condition. The medicine must fulfil certain criteria … designation as an orphan medicine so that it can benefit from … -
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Orphan designation: Autologous CD34+ haematopoietic stem and progenitor cells genetically modified with a lentiviral vector encoding for the N-acetylgalactosamine 6-sulfatase cDNA for: Treatment of mucopolysaccharidosis type IV A (Morquio A syndrome)
Date of designation: 10/08/2022, Positive, Last updated: 15/12/2022stem and progenitor cells genetically modified with a lentiviral vector … 6-sulfatase cDNA Overview This medicine was designated as an A medicine for the diagnosis, prevention … 781 6000 © European Medicines Agency, 2022. Reproduction … -
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Orphan designation: Autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector encoding for the human iduronate 2-sulfatase gene for: Treatment of mucopolysaccharidosis type II (Hunter's syndrome)
Date of designation: 20/08/2021, Positive, Last updated: 02/03/2022for A status assigned to a medicine intended for use against … against a rare condition. The medicine must fulfil certain criteria … designation as an orphan medicine so that it can benefit from … -
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Opinion/decision on a Paediatric investigation plan (PIP): Autologous human T cells genetically modified ex-vivo with a lentiviral vector encoding a chimeric antigen receptor (CAR) for B-cell maturation antigen (BCMA) (JNJ-68284528)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002585-PIP01-19, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for infusion
Decision date: 04/10/2019, Last updated: 25/03/2020, Compliance check: XAutologous human T cells genetically modified ex-vivo with a lentiviral … 2019 on the granting of a product specific waiver for autologous … autologous human T cells genetically …