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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
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)

​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

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)

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

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

​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

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

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

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

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

​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

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

​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

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

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

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 retiré par le notifiant
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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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)

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
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 retiré par le notifiant
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 retiré par le notifiant
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

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

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