GM medicinal products

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
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

 Link to 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)

 Link to 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Dossier withdrawn by the notifier 		Link to EMA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)

 Link to 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

 Link to 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

 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
17/12/2020: Authorized in the EU

 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"
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

 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"
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

 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
01/07/2020: Authorized in the EU

 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
01/07/2020: Authorized in the EU

 Link to 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

 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
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

 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"
04/10/2019: Opinion on the "Day 150 Assessment Report"

31/01/2020: Positive opinion of EMA
01/04/2020: Authorized in the EU

 Link to 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

 Link to 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

 Link to 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

 Link to 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

 Link to 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

 Link to 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 Link to 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

 Link to 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

 Link to 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

 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"
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

 Link to 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

 Link to 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

 Link to 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

 Link to 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

 Link to 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

 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
15/06/2012: Authorised in the EU

 Link to 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

 Link to 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

 Link to 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

 Link to 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

 Link to 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

 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"
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)

 Link to 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 withdrawn by the notifier 		Link to 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 Link to 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 Link to 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

 Link to 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

 Link to 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 withdrawn by the notifier 		Link to EMA