Dossiers concerning genetically modified medicinal products - Submitted according to Regulation (EC) 726/2004
Ref. | GMO | Applicant | Advice of the Council (consultation on the Environmental Risk Assessment organised by EMA) | Status | Link to 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 to 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 to 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 to 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 to 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 to 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 to 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 to 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 to 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 to 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 to 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 to 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 to 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 to 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 to 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 to EMA |
Raligize |
Treatment of cervical cancer |
Advaxis, Inc. |
06/07/2018: Opinion on the dossier and the "Day 80 Assessment Report" |
Dossier withdrawn by the notifier | Link to 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 to 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 to 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 to 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 to 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 to 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 to 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 to 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 to 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 to 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 to 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 to 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 to 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 to 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 to 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 to 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 to 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 withdrawn by the notifier |
Link to EMA |
Contusugene ladenovec Gendux |
Gene therapy product |
Gendux Molecular Limited |
27/11/2008: Opinion on the dossier and the "Day 80 Assessment Report" |
Dossier withdrawn by the notifier | Link to EMA |
Advexin |
Genetically modified virus |
Introgen Therapeutics |
04/04/2008: Opinion on the dossier and the "Day 80 Assessment Report" |
Dossier withdrawn by the notifier | Link to 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 to 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 to 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 withdrawn by the notifier |
Link to EMA |