20318 results
-
List item
Human medicine European public assessment report (EPAR): Breyanzi (updated)
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,
, Revision: 1, Authorised, Last updated: 25/05/2023
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, 2023. Reproduction … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Breyanzi, Lisocabtagene maraleucel
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001995-PIP01-16-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for infusion
Decision date: 31/12/2021, Last updated: 28/03/2023, Compliance check: XEMA/708327/2021 European Medicines Agency decision P/0558/2021 … authentic. European Medicines Agency decision EMA/708327/2021 … EMA/708327/2021 Page 2/3 European Medicines Agency decision P/0558/2021 … -
List item
Summary of opinion: Eurican L4
inactivated immunological veterinary medicinal product containing Leptospira interrogans, serogroup Canicola, serovar Canicola, strain 16070, L. interrogans, serogroup icterohaemorrhagiae, serovar icterohaemorrhagiae, strain 16069, L. interrogans, serogroup Grippotyphosa, serovar Grippotyphosa, strain Grippo Mal 1540, L. interrogans, serogroup Australis, serovar Bratislava, strain, opinion date: 15/02/2023, Positive, Last updated: 17/02/2023immunological veterinary medicinal product containing Leptospira interrogans … questions concerning veterinary medicines. Abbreviated as CVMP. More … 039;Committee for Veterinary Medicinal … -
List item
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 … -
List item
Orphan designation: Genetically modified human adenovirus encoding human PH20 hyaluronidase for: Treatment of pancreatic cancer
Date of designation: 21/06/2011, Positive, Last updated: 31/07/2013Biosciences S.L., Spain, for genetically modified human adenovirus encoding … the Committee for Orphan Medicinal Products (COMP). *Disclaimer: For … opinion on orphan designation Genetically modified human adenovirus encoding … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Single strain of non-genetically modified Prevotella histicola (EDP1815)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Dermatology
PIP number: EMEA-002933-PIP01-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral solid dosage form, Capsule, hard
Decision date: 31/01/2022, Last updated: 05/04/2023, Compliance check: Xsubstance Single strain of non-genetically modified Prevotella histicola (EDP1815 … EMA/9458/2022 European Medicines Agency decision P/0008/2022 … for single strain of non-genetically modified Prevotella histicola (EDP1815 … -
List item
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 … -
List item
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: 10/11/2022Limited, United Kingdom, for genetically modified replication-incompetent herpes … genes responsible for the production of certain proteins that … the Committee for Orphan Medicinal … -
List item
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: 20/12/2022This medicine was designated as an orphan medicine for the treatment of mucopolysaccharidosis … from EMA to advance their medicine to the stage where they can … designation does not mean the medicine is available or authorised … -
List item
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: 14/07/2022autologous haematopoietic cells genetically modified with a lentiviral vector … gene is responsible for the production of a protein called gp91(phox … the Committee for Orphan Medicinal … -
List item
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: 19/03/2021Therapeutics Oy, Finland, for genetically modified serotype 5/3 adenovirus coding … the Committee for Orphan Medicinal Products (COMP). *Disclaimer: For … opinion on orphan designation Genetically modified serotype 5/3 adenovirus coding … -
List item
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: 19/03/2021Therapeutics Oy, Finland, for genetically modified serotype 5/3 adenovirus coding … the Committee for Orphan Medicinal Products (COMP) . *Disclaimer: For … opinion on orphan designation Genetically modified serotype 5/3 adenovirus coding … -
List item
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: 29/03/2016ActoGeniX N.V., Belgium, for genetically modified Lactococcus lactis bacteria … the Committee for Orphan Medicinal Products (COMP). *Disclaimer: For … Genetically modified Lactococcus lactis bacteria … -
List item
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 … genes responsible for the production of certain proteins that … the Committee for Orphan Medicinal … -
List item
Orphan designation: Autologous hematopoietic cells genetically modified with a lentiviral vector containing the human RAG2 gene for: Treatment of recombination-activating gene 2 deficient severe combined immunodeficiency
Date of designation: 13/01/2023, Positive, Last updated: 23/03/2023tologous hematopoietic cells genetically modified with a lentiviral vector … 781 6000 © European Medicines Agency, 2023. Reproduction … EMA/COMP/946245/2022 Human Medicines Division Committee for … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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: 05/12/20222020, 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 … -
List item
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: 19/03/2021Therapeutics Oy, Finland, for genetically modified serotype 5/3 adenovirus coding … the Committee for Orphan Medicinal Products (COMP) . *Disclaimer: For … www.ema.europa.eu © European Medicines Agency, 2014. Reproduction … -
List item
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: 11/07/2017Clinipace GmbH, Germany, for genetically modified adeno-associated viral vector … the Committee for Orphan Medicinal Products (COMP). *Disclaimer: For … opinion on orphan designation Genetically modified adeno-associated viral vector … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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 … gravis. Please note that this product was withdrawn from the Community … Register of designated Orphan Medicinal …