Dossiers betreffende genetisch gemodificeerde geneesmiddelen - ingediend onder Verordening (EG) 726/2004
Ref. | GGO | Aanvrager | Advies van de Raad (consultatie betreffende de evaluatie van de risico's voor het leefmilieu door EMA georganiseerd) | Status | Link naar 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 |
Link naar EMA |
Vaxzevria (ChAdOx1-S) | COVID-19 vaccine |
AstraZeneca | 13/01/2021: Opinion on the dossier and the "Day 80 Assessment Report" |
29/01/2021: Positive opinion of EMA |
Link naar EMA |
Skysona h-3690 (Elivaldogene autotemcel) | GM autologous |
Bluebird Bio B.V. | 08/01/2021: Opinion on the dossier and the "Day 80 Assessment Report" |
20/05/2021: Positive opinion of EMA |
Link naar EMA |
COVID-19 Vaccine Janssen (Ad26.COV2.S) | COVID-19 vaccine |
Janssen-Cilag International NV | 05/01/2021: Risk assessment report on GMO environmental risk assessment |
11/03/2021: Positive opinion of EMA |
Link naar 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 |
Link naar 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 |
Link naar 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 |
Link naar 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" |
17/02/2021: Positive opinion of EMA |
Link naar 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" |
07/10/2020: Positive opinion of EMA |
Link naar 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 |
Link naar 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 |
Link naar EMA |
Innovax-ND-MD | Cell-associated live recombinant herpes virus |
Intervet International | 04/11/2019: Advice on GMO env. risk assessment |
17/07/2020: Positive opinion of EMA |
Link naar EMA |
Ervebo | Vaccination of humans against Ebola |
Merck Sharp & Dohme B.V. | 20/05/2019: Risk assessment report on GMO environmental risk assessment |
18/10/2019: Positive opinion of EMA |
Link naar 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" |
31/01/2020: Positive opinion of EMA |
Link naar EMA |
Vectormune FP+ILT+AE | Vaccination of chickens for |
CEVA | 18/03/2019: Opinion on the dossier and the "Day 80 Assessment Report" |
21/02/2020: Positive opinion of EMA |
Link naar EMA |
Prevexxion RN | Vaccination of chickens |
Merial | 18/03/2019: Opinion on the dossier and the "Day 80 Assessment Report" |
25/05/2020: Positive opinion of EMA |
Link naar EMA |
Prevexxion RN+HVT+IBD | Vaccination of chickens |
Merial | 18/03/2019: Opinion on the dossier and the "Day 80 Assessment Report" |
25/05/2020: Positive opinion of EMA |
Link naar EMA |
Zolgensma | Treatment of paediatric |
AveXis | 08/02/2019: Opinion on the dossier and the "Day 80 Assessment Report" |
27/03/2020: Positive opinion of EMA |
Link naar EMA |
Zynteglo (formerly Glovalto) | Treatment of patients with transfusion-dependent β-thalassemia |
Bluebird Bio | 11/01/2019: Opinion on the dossier and the "Day 80 Assessment Report" |
29/03/2019: Positive opinion of EMA |
Link naar EMA |
Raligize | Treatment of cervical cancer |
Advaxis, Inc. | 06/07/2018: Opinion on the dossier and the "Day 80 Assessment Report" |
Dossier teruggetrokken door de kennisgever | Link naar EMA |
Kymriah | Treatment of adult patients |
Novartis | 01/03/2018: Opinion on the dossier and the "Day 80 Assessment Report" |
28/06/2018: Positive opinion of EMA |
Link naar EMA |
Yescarta | Treatment of adult patients |
Kite Pharma EU B.V. | 30/11/2017: Opinion on the dossier and the "Day 80 Assessment Report" |
28/06/2018: Positive opinion of EMA |
Link naar EMA |
Luxturna | Recombinant adeno-associated virus |
Spark Therapeutics, Ink | 27/11/2017: Opinion on the dossier and the "Day 80 Assessment Report" |
22/11/2018: Authorized in the EU |
Link naar 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" |
19/10/2018: Positive opinion of EMA |
Link naar EMA |
Strimvelis | CD34+ cells with recombinant retroviral vector |
GSK | 08/09/2015: Opinion on the dossier and the "Day 80 Assessment Report" |
01/04/2016: Positive opinion of EMA |
Link naar EMA |
Vectormune ND | Live recombinant herpes virus |
CEVA Ltd | 11/08/2014: Opinion on the dossier and the "Day 70 Assessment Report" |
10/07/2015: Positive opinion of EMA |
Link naar EMA |
Zalmoxis | Allogeneic GM T cells with recombinant retroviral vector |
Molmed | 10/07/2014: Opinion on the dossier and the "Day 80 Assessment Report" |
24/06/2016: Positive opinion of EMA |
Link naar EMA |
Innovax-ILT | Cell-associated live recombinant herpes virus |
Intervet International | 10/06/2014: Opinion on the dossier and the "Day 70 Assessment Report" |
07/05/2015: Positive opinion of EMA |
Link naar EMA |
Oncept IL-2 | Recombinant canarypox virus |
Merial | 07/02/2012: Opinion on the dossier and the "Day 70 Assessment Report" |
07/03/2013: Positive opinion of EMA |
Link naar 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 |
Link naar EMA |
Proteq West Nile | Recombinant canarypox virus |
Merial | 26/08/2010: Opinion on the dossier and the "Day 70 Assessment Report" |
09/06/2011: Positive opinion of EMA |
Link naar EMA |
Nobivac Myxo-RHD | Live myxoma recombinant virus |
Intervet International | 17/05/2010: Opinion on the dossier and the "Day 70 Assessment Report" |
14/07/2011: Positive opinion of EMA |
Link naar EMA |
Glybera | Recombinant adeno-associated virus |
Amsterdam Molecular Therapeutics | 30/04/2010: Opinion on the dossier and the "Day 80 Assessment Report" |
24/06/2011: Negative opinion of EMA |
Link naar EMA |
Purevax rabies | Recombinant canarypox virus |
Merial | 15/03/2010: Opinion on the dossier and the "Day 70 Assessment Report" |
08/12/2010: Positive opinion of EMA |
Link naar EMA |
Hiprabovis IBR marker live | Recombinant herpes virus |
Laboratorios HIPRA S.A. | 15/06/2009: Opinion on the dossier and the "Day 70 Assessment Report" |
12/11/2010: Positive opinion of EMA |
Link naar EMA |
Fluenz | Live attenuated vaccine against influenza virus (humans) |
MedImmune LLC | 08/04/2009: Opinion on the dossier and the "Day 80 Assessment Report" |
21/10/2010: Positive opinion of EMA |
Link naar EMA |
Cerepro | Recombinant adenovirus |
Ark Therapeutics Ltd | 25/03/2009: Opinion on the dossier and the "Day 80 Assessment Report" |
17/12/2009: Negative opinion of EMEA Dossier teruggetrokken door de kennisgever |
Link naar EMA |
Contusugene ladenovec Gendux | Gene therapy product |
Gendux Molecular Limited | 27/11/2008: Opinion on the dossier and the "Day 80 Assessment Report" |
Dossier teruggetrokken door de kennisgever | Link naar EMA |
Advexin | Genetically modified virus |
Introgen Therapeutics | 04/04/2008: Opinion on the dossier and the "Day 80 Assessment Report" |
Dossier teruggetrokken door de kennisgever | Link naar EMA |
ProteqFluTe | Recombinant canarypox virus |
Merial | 08/10/2007: Opinion on the dossier and the "Assessment Report" |
06/03/2003: Authorised in the EU |
Link naar EMA |
ProteqFlu | Recombinant canarypox virus |
Merial | 08/10/2007: Opinion on the dossier and the "Assessment Report" |
06/03/2003: Authorised in the EU |
Link naar EMA |
Cerepro | Recombinant adenovirus |
Ark Therapeutics Ltd | 02/02/2006: Opinion on the dossier and the "Day 70 Assessment Report" |
26/04/2007: Negative opinion of EMEA Dossier teruggetrokken door de kennisgever |
Link naar EMA |