Produits médicinaux GM

Dossiers concernant les produits médicinaux génétiquement modifiés - Soumis dans le cadre du Règlement (CE) 726/2004

Réf.	OGM	Notifiant	Avis du Conseil (consultation sur l'évaluation du risque environnemental organisée par l'EMA)	État des lieux	Lien EMA
Ixchiq	Attenuated recombinant chikungunya virus for immunisation for the prevention of disease caused by chikungunya virus in individuals 18 years and older	Valneva Austria GmbH	19/01/2024: Advice on GMO envir. risk assessment	30/05/2024: Positive opinion of EMA 28/06/2024: Authorized in the EU	Lien EMA
Casgevy	Autologous CD34+ human hematopoietic stem and progenitor cells for treatment against transfusion-dependent β-thalassemia or sickle cell disease	Vertex Pharmaceuticals Incorporated	04/05/2023: Advice on GMO envir. risk assessment	14/12/2023: Positive opinion of EMA 09/02/2024: Authorized in the EU	Lien EMA
Hemgenix	Recombinant, replication-deficient adenovirus for treatment against Hemophilia B with FIX deficiency	CSL Behring GmbH	30/06/2022: Advice on GMO envir. risk assessment	16/12/2022: Positive opinion of EMA 20/02/2023: Authorized in the EU	Lien EMA
Newflend ND H9	Live recombinant turkey herpesvirus for vaccination against low pathogenic avian influenza virus, subtype H9	CEVA-Phylaxia Co. Ltd	23/03/2022: Advice on GMO envir. risk assessment	23/03/2023: Positive opinion of EMA 15/05/2023: Authorized in the EU	Lien EMA
Qdenga	Four recombinant live attenuated dengue virus strains for vaccination against dengue disease	Takeda	11/10/2021: Advice on GMO envir. risk assessment	14/10/2022: Positive opinion of EMA 05/12/2022: Authorized in the EU	Lien EMA
Carvykti	GM autologous T-cell immunotherapy (lentiviral vector) for treatment of adult patients with relapsed or refractory multiple myeloma	Janssen-Cilag International NV	30/08/2021: Advice on GMO envir. risk assessment	25/03/2022: Positive opinion of EMA 25/05/2022: Authorized in the EU	Lien EMA
Vaxzevria (ChAdOx1-S)	COVID-19 vaccine (GM chimpanzee adenovirus)	AstraZeneca	13/01/2021: Opinion on the dossier and the "Day 80 Assessment Report"	29/01/2021: Positive opinion of EMA 29/01/2021: Authorized in the EU (conditional)	Lien EMA
Skysona h-3690 (Elivaldogene autotemcel)	GM autologous T-cell immunotherapy (lentiviral vector) for treatment of patients with cerebral adrenoleukodystrophy	Bluebird Bio B.V.	08/01/2021: Opinion on the dossier and the "Day 80 Assessment Report"	20/05/2021: Positive opinion of EMA 16/07/2021: Authorized in the EU Dossier retiré par le notifiant	Lien EMA
COVID-19 Vaccine Janssen (Ad26.COV2.S)	COVID-19 vaccine (GM adenovirus type 26)	Janssen-Cilag International NV	05/01/2021: Risk assessment report on GMO environmental risk assessment	11/03/2021: Positive opinion of EMA 11/03/2021: Authorized in the EU (conditional)	Lien EMA
Breyanzi	GM autologous T-cell immunotherapy (lentiviral vector) for treatment of patients with lymphoma	Celgene Europe B.V.	28/10/2020: Advice on GMO envir. risk assessment	28/01/2022: Positive opinion of EMA 04/04/2022: Authorized in the EU	Lien EMA
Abecma	GM autologous T-cell immunotherapy (lentiviral vector) for treatment of patients with multiple myeloma	Celgene Europe B.V.	04/09/2020: Advice on GMO envir. risk assessment	25/06/2021: Positive opinion of EMA 18/08/2021: Authorized in the EU	Lien EMA
Upstaza	Recombinant adeno-associated virus serotype 2 for treatment against aromatic L amino acid decarboxylase (AADC) deficiency	PTC Therapeutics International Limited	15/05/2020: Advice on GMO envir. risk assessment	20/05/2022: Positive opinion of EMA 18/07/2022: Authorized in the EU	Lien EMA
Libmeldy	Treatment of metachromatic leukodystrophy (MLD)	Orchard Therapeutics	06/03/2020: Opinion on the dossier and the "Day 80 Assessment Report"	16/10/2020: Positive opinion of EMA 17/12/2020: Authorized in the EU	Lien EMA
Ultifend ND IBD	Vaccination of chickens against Newcastle disease virus, Infectious Bursal Disease virus and Marek's disease virus	CEVA-Phylaxia Veterinary Biologicals	20/02/2020: Opinion on the dossier and the "Day 80 Assessment Report" 20/10/2020: Opinion on the "Day 120 Assessment Report" 02/02/2021: Opinion on the "Day 190 Assessment Report"	17/02/2021: Positive opinion of EMA	Lien EMA
Nobivac DP Plus	Vaccination of puppies against canine distemper virus and canine parvovirus	Intervet International	20/02/2020: Opinion on the dossier and the "Day 80 Assessment Report" 25/06/2020: Opinion on the "Day 120 Assessment Report" 23/09/2020: Opinion on the "Day 180 Assessment Report"	07/10/2020: Positive opinion of EMA 09/12/2020: Authorized in the EU	Lien EMA
MVABbea	Vaccination of humans against Ebola	Janssen-Cilag International NV	07/02/2020: Opinion on the dossier and the "Day 80 Assessment Report"	29/05/2020: Positive opinion of EMA 01/07/2020: Authorized in the EU	Lien EMA
Zabdeno	Vaccination of humans against Ebola	Janssen-Cilag International NV	07/02/2020: Opinion on the dossier and the "Day 80 Assessment Report"	29/05/2020: Positive opinion of EMA 01/07/2020: Authorized in the EU	Lien EMA
Innovax-ND-MD	Cell-associated live recombinant herpes virus (vaccination of chickens)	Intervet International	04/11/2019: Advice on GMO env. risk assessment 08/05/2020: Advice on D160 assessment report	17/07/2020: Positive opinion of EMA 16/09/2020: Authorised in the EU	Lien EMA
Ervebo	Vaccination of humans against Ebola	Merck Sharp & Dohme B.V.	20/05/2019: Risk assessment report on GMO environmental risk assessment 05/09/2019: Day-106 Response assessment report 01/10/2019: Day-120 Response assessment report	18/10/2019: Positive opinion of EMA 11/11/2019: Authorized in the EU	Lien EMA
Vaxchora	Vaccination of humans for the prevention of cholera	Emergent Netherlands B.V.	10/05/2019: Opinion on the dossier and the "Day 80 Assessment Report" 04/10/2019: Opinion on the "Day 150 Assessment Report"	31/01/2020: Positive opinion of EMA 01/04/2020: Authorized in the EU	Lien EMA
Vectormune FP+ILT+AE	Vaccination of chickens for control of fowlpox and infectious laryngotracheitis diseases + control of avian encephalomyelitis	CEVA	18/03/2019: Opinion on the dossier and the "Day 80 Assessment Report" 25/10/2019: Opinion on the "Day 160 Assessment Report"	21/02/2020: Positive opinion of EMA 24/04/2020: Authorized in the EU	Lien EMA
Prevexxion RN	Vaccination of chickens against Marek's disease	Merial	18/03/2019: Opinion on the dossier and the "Day 80 Assessment Report"	25/05/2020: Positive opinion of EMA 20/07/2020: Authorized in the EU	Lien EMA
Prevexxion RN+HVT+IBD	Vaccination of chickens against Marek's and Gumboro's diseases	Merial	18/03/2019: Opinion on the dossier and the "Day 80 Assessment Report"	25/05/2020: Positive opinion of EMA 20/07/2020: Authorized in the EU	Lien EMA
Zolgensma	Treatment of paediatric patients with spinal muscular atrophy (recombinant adeno- associated virus)	AveXis	08/02/2019: Opinion on the dossier and the "Day 80 Assessment Report" 11/06/2019: Opinion on the "Day 150 Assessment Report"	27/03/2020: Positive opinion of EMA 18/05/2020: Authorized in the EU	Lien EMA
Zynteglo (formerly Glovalto)	Treatment of patients with transfusion-dependent β-thalassemia (engineered autologous cell therapy)	Bluebird Bio	11/01/2019: Opinion on the dossier and the "Day 80 Assessment Report" 15/03/2019: Opinion on the "Day 120 Assessment Report"	29/03/2019: Positive opinion of EMA 29/05/2019: Authorized in the EU	Lien EMA
Raligize	Treatment of cervical cancer (therapeutic immunotherapy with live attenuated GM Lysteria monocytogenes)	Advaxis, Inc.	06/07/2018: Opinion on the dossier and the "Day 80 Assessment Report"	Dossier withdrawn by the notifier	Lien EMA
Kymriah	Treatment of adult patients with blood cancers (autologous cell therapy involving genetic modification of patient's own T cells)	Novartis	01/03/2018: Opinion on the dossier and the "Day 80 Assessment Report" 18/05/2018: Opinion on the "Day 150 Assessment Report"	28/06/2018: Positive opinion of EMA 22/08/2018: Authorized in the EU	Lien EMA
Yescarta	Treatment of adult patients with blood cancers (autologous cell therapy involving genetic modification of patient's own T cells)	Kite Pharma EU B.V.	30/11/2017: Opinion on the dossier and the "Day 80 Assessment Report" 06/04/2018: Opinion on the "Day 120 Assessment Report" 20/06/2018:Opinion on the "Day 180 Assessment Report"	28/06/2018: Positive opinion of EMA 23/08/2018: Authorized in the EU	Lien EMA
Luxturna	Recombinant adeno-associated virus (treatment of adults and children with loss of vision due to inherited retinal dystrophy)	Spark Therapeutics, Ink	27/11/2017: Opinion on the dossier and the "Day 80 Assessment Report" 30/04/2018: Opinion on the "Day 120 Assessment Report" 11/07/2018:Opinion on the "Day 195 Assessment Report"	22/11/2018: Authorized in the EU	Lien EMA
Dengvaxia	Live attenuated recombinant virus for vaccination against Dengue disease	Sanofi Pasteur	24/05/2016: Opinion on the dossier and the "Day 80 Assessment Report" 31/01/2017: Opinion on the "Day 120 Assessment Report" 31/03/2018:Opinion on the "Day 180 Assessment Report"	19/10/2018: Positive opinion of EMA 12/12/2018: Authorized in the EU	Lien EMA
Strimvelis	CD34+ cells with recombinant retroviral vector (treatment of patients with severe immuno-deficiency)	GSK	08/09/2015: Opinion on the dossier and the "Day 80 Assessment Report" 15/02/2016: Opinion on the "Day 120 Assessment Report"	01/04/2016: Positive opinion of EMA 26/05/2016: Authorized in the EU	Lien EMA
Vectormune ND	Live recombinant herpes virus (vaccination of chickens)	CEVA Ltd	11/08/2014: Opinion on the dossier and the "Day 70 Assessment Report" 27/04/2015: Opinion on the "Day 120 Assessment Report"	10/07/2015: Positive opinion of EMA 08/09/2015: Authorized in the EU	Lien EMA
Zalmoxis	Allogeneic GM T cells with recombinant retroviral vector (adjunctive treatment post bone marrow transplantation)	Molmed	10/07/2014: Opinion on the dossier and the "Day 80 Assessment Report" 11/03/2015: Opinion on the "Day 120 Assessment Report" 12/01/2016:Opinion on the "Day 180 Assessment Report"	24/06/2016: Positive opinion of EMA 18/08/2016: Authorized in the EU	Lien EMA
Innovax-ILT	Cell-associated live recombinant herpes virus (vaccination of chickens)	Intervet International	10/06/2014: Opinion on the dossier and the "Day 70 Assessment Report" 03/03/2015: Opinion on the "Day 120 Assessment Report" 03/03/2015: Opinion on outstanding issues	07/05/2015: Positive opinion of EMA 03/07/2015: Authorised in the EU	Lien EMA
Oncept IL-2	Recombinant canarypox virus (therapeutic vaccination of cats)	Merial	07/02/2012: Opinion on the dossier and the "Day 70 Assessment Report" 26/10/2012: Opinion on the "Day 120 Assessment Report"	07/03/2013: Positive opinion of EMA 03/05/2013: Authorised in the EU	Lien EMA
Poulvac E. Coli	Live bacteria Escherichia coli(vaccination of chickens)	Pfizer Ltd	09/05/2011: Opinion on the dossier and the "Day 70 Assessment Report"	13/07/2012: Positive opinion of EMA 15/06/2012: Authorised in the EU	Lien EMA
Proteq West Nile	Recombinant canarypox virus (vaccination of horses)	Merial	26/08/2010: Opinion on the dossier and the "Day 70 Assessment Report" 08/04/2011: Opinion on the "Day 150 Assessment Report"	09/06/2011: Positive opinion of EMA 05/08/2011: Authorised in the EU	Lien EMA
Nobivac Myxo-RHD	Live myxoma recombinant virus (vaccination of rabbits)	Intervet International	17/05/2010: Opinion on the dossier and the "Day 70 Assessment Report"	14/07/2011: Positive opinion of EMA 07/09/2011: Authorised in the EU	Lien EMA
Glybera	Recombinant adeno-associated virus (treatment of humans with lipoprotein lipase deficiency)	Amsterdam Molecular Therapeutics	30/04/2010: Opinion on the dossier and the "Day 80 Assessment Report" 10/01/2011: Opinion on the "Day 120 Assessment Report" 09/05/2011:Opinion on the "Day 150 Assessment Report"	24/06/2011: Negative opinion of EMA 19/06/2011: Revised positive opinion of EMA 25/10/2012: Authorised in the EU	Lien EMA
Purevax rabies	Recombinant canarypox virus (vaccination of cats)	Merial	15/03/2010: Opinion on the dossier and the "Day 70 Assessment Report" 28/10/2010: Opinion on the "Day 120 Assessment Report"	08/12/2010: Positive opinion of EMA 18/02/2011: Authorised in the EU	Lien EMA
Hiprabovis IBR marker live	Recombinant herpes virus (vaccination of bovines)	Laboratorios HIPRA S.A.	15/06/2009: Opinion on the dossier and the "Day 70 Assessment Report"	12/11/2010: Positive opinion of EMA 27/01/2011: Authorised in the EU	Lien EMA
Fluenz	Live attenuated vaccine against influenza virus (humans)	MedImmune LLC	08/04/2009: Opinion on the dossier and the "Day 80 Assessment Report" 17/06/2010: Opinion on the "Day 120 Assessment Report" 13/09/2010: Opinion on the "Day 150 Assessment Report"	21/10/2010: Positive opinion of EMA 27/01/2011: Authorised in the EU Withdrawn on 03/12/2014 and replaced by Fluenz Tetra (authorized on 03/12/2014)	Lien EMA
Cerepro	Recombinant adenovirus (treatment of brain tumours in humans)	Ark Therapeutics Ltd	25/03/2009: Opinion on the dossier and the "Day 80 Assessment Report"	17/12/2009: Negative opinion of EMEA Dossier retiré par le notifiant	Lien EMA
Contusugene ladenovec Gendux	Gene therapy product (treatment of cancers in humans)	Gendux Molecular Limited	27/11/2008: Opinion on the dossier and the "Day 80 Assessment Report"	Dossier withdrawn by the notifier	Lien EMA
Advexin	Genetically modified virus (treatment of Li-Fraumeni cancer in humans)	Introgen Therapeutics	04/04/2008: Opinion on the dossier and the "Day 80 Assessment Report"	Dossier withdrawn by the notifier	Lien EMA
ProteqFluTe	Recombinant canarypox virus (immunization of horses)	Merial	08/10/2007: Opinion on the dossier and the "Assessment Report"	06/03/2003: Authorised in the EU	Lien EMA
ProteqFlu	Recombinant canarypox virus (immunization of horses)	Merial	08/10/2007: Opinion on the dossier and the "Assessment Report"	06/03/2003: Authorised in the EU	Lien EMA
Cerepro	Recombinant adenovirus (treatment of brain tumours in humans)	Ark Therapeutics Ltd	02/02/2006: Opinion on the dossier and the "Day 70 Assessment Report" 27/10/2006: Opinion on the "Day 120 Assessment Report"	26/04/2007: Negative opinion of EMEA Dossier retiré par le notifiant	Lien EMA