Marketing authorisations for GMO-medicinal products for human use

Ten products have received marketing authorisation so far (for more details on the product and the authorisation procedure click on the corresponding link):

 

Fluenz (now replaced by Fluenz Tetra)
Application number EMEA/H/C/001101
Marketing authorisation holder MedImmune LLC
Name of the product Fluenz
Active substances Influenza virus reassortants
Parental organism Live attenuated strain of Influenza virus
Transgene(s) Influenza virus reassortants for each of the 3 strains selected for the yearly season
Treated organism Humans: children en adolescents
Indication(s) Vaccination against influenza A (subtypes H1N1 and H3N2) and influenza B
Administration route(s) Nasal spray
Type of authorisation Centralised at European level
Legal frame Council regulation (EC) No 726/2004 and the environmental safety requirements laid down by European Directive 2001/18/EC, part C and the Royal Decree of 21/02/2005, article 27
Competent authority EMA/European Commission
Belgian advisory body Biosafety Advisory Council
Date of the advices of the Biosafety Advisory Council 08/04/2009, 17/06/2010, 13/09/2010
EMA (CHMP) opinion (date) Positive (27/10/2010)
European Commission authorisation number (date) EU/1/10/661 (27/01/2011)
European Commission decision Community register of medicinal products
European Public Assessment Report (including EMA opinion, Product information leaflet and Summary of product characteristics in all EU languages) EPAR (link to Web site of EMA)
Notifications to Belgian authorities while in Research and Development stage None

 

Glybera
Application number EMEA/H/C/2145
Marketing authorisation holder uniQure biopharma B.V.
Name of the product Glybera
Active substances Viral vector
Parental organism Protein shell deived from adeno-associated virus serotype 1
Transgene(s) Human lipoprotein lipase
Treated organism Humans: adults
Indication(s) Lipoprotein lipase deficiency (LPLD)
Administration route(s) Intramuscular
Type of authorisation Centralised at European level
Legal frame Council regulation (EC) No 726/2004 and the environmental safety requirements laid down by European Directive 2001/18/EC, part C and the Royal Decree of 21/02/2005, article 27
Competent authority EMA/European Commission
Belgian advisory body Biosafety Advisory Council
Date of the advices of the Biosafety Advisory Council 30/04/2010, 10/01/2011, 09/05/2011
EMA (CHMP) opinion (date) Positive (19/07/2012)
European Commission authorisation number (date) EU/1/12/791 (25/10/2012) - with restricted access programme
European Commission decision Community register of medicinal products
European Public Assessment Report (including EMA opinion, Product information leaflet and Summary of product characteristics in all EU languages) EPAR (link to Web site of EMA)
Notifications to Belgian authorities while in Research and Development stage None

 

Imlygic
Application number EMEA/H/C/002771
Marketing authorisation holder Amgen Europe B.V.
Name of the product Imlygic
Active substances Talimogene laherparepvec (oncolytic virus)
Parental organism Herpes simplex virus 1
Transgene(s) Immune stimulatory protein human GM-CSF
Treated organism Humans: adults
Indication(s) Treatment of melanomas
Administration route(s) Injection into melanoma tumours
Type of authorisation Centralised at European level
Legal frame Council regulation (EC) No 726/2004 and the environmental safety requirements laid down by European Directive 2001/18/EC, part C and the Royal Decree of 21/02/2005, article 27
Competent authority EMA/European Commission
Belgian advisory body Biosafety Advisory Council
Date of the advice of the Biosafety Advisory Council Not assesed by the Council
EMA (CHMP) opinion (date) Positive (22/10/2015)
European Commission authorisation number (date) EU/1/15/1064 (16/12/2015)
European Commission decision Community register of medicinal products
European Public Assessment Report (including EMA opinion, Product information leaflet and Summary of product characteristics in all EU languages) EPAR (link to Web site of EMA)
Notifications to Belgian authorities while in Research and Development stage B/BE/14/BVW1, B/BE/15/BVW1 (links to the Belgian Biosafety Server)

 

Pandemic Influenza vaccine H5N1 AstraZeneca
Application number EMEA/H/C/003963
Marketing authorisation holder AstraZeneca AB 
Name of the product Pandemic Influenza vaccine H5N1 Astra Zeneca 
Active substances Pandemic Influenza vaccine H5N1 (live attenuated, nasal)
Parental organism Live attenuated influenza A virus A/Vietnam/1203/2004 (H5N1) strain
Transgene(s)  
Treated organism Humans: children and adolescents
Indication(s) Prophylaxis of influenza in an officially declared pandemic situation in children and adolescents from 12 months to less than 18 years of age
Administration route(s) Intranasal route 
Type of authorisation Centralised at European level (orphan status)
Legal frame Council regulation (EC) No 726/2004 and the environmental safety requirements laid down by European Directive 2001/18/EC, part C and the Royal Decree of 21/02/2005, article 27
Competent authority EMA/European Commission
Belgian advisory body Biosafety Advisory Council
Date of the advice of the Biosafety Advisory Council None
EMA (CHMP) opinion (date) Positive (01/04/2016)
European Commission authorisation number (date) EU/1/16/1089 (20/05/2016)
European Commission decision Community register of medicinal products
European Public Assessment Report (including EMA opinion, Product information leaflet and Summary of product characteristics in all EU languages) EPAR (link to Web site of EMA)
Notifications to Belgian authorities while in Research and Development stage None

 

Zalmoxis
Application number EMEA/H/C/2801
Marketing authorisation holder MolMed S.p.A.
Name of the product Zalmoxis
Active substances Allogeneic T cells
Parental organism T-cells obtained from haploidentical donors
Transgene(s) Truncated form of the human low affinity nerve growth factor receptor and the herpes simplex I virus thymidine kinase
Treated organism Humans: adults
Indication(s) Adjunctive treatment in haploidentical haematopoietic stem cell transplantation (HSCT) of adult patients with high-risk haematological malignancies
Administration route(s) Intravenous infusion following cell thawing
Type of authorisation Centralised at European level
Legal frame Council regulation (EC) No 726/2004 and the environmental safety requirements laid down by European Directive 2001/18/EC, part C and the Royal Decree of 21/02/2005, article 27
Competent authority EMA/European Commission
Belgian advisory body Biosafety Advisory Council
Date of the advices of the Biosafety Advisory Council 11/03/2015, 12/01/2016, 21/03/2016
EMA (CHMP) opinion (date) Positive (24/06/2016)
European Commission authorisation number (date) EU/1/16/1121 (18/08/2016)
European Commission decision Community register of medicinal products
European Public Assessment Report (including EMA opinion, Product information leaflet and Summary of product characteristics in all EU languages) EPAR (link to Web site of EMA)
Notifications to Belgian authorities while in Research and Development stage None

 

Strimvelis
Application number EMEA/H/C/003854
Marketing authorisation holder GlaxoSmithKline Trading Services Limited
Name of the product Strimvelis
Active substances autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence
Parental organism CD34+ cells extracted from the patient’s bone marrow
Transgene(s) Human adenosine deaminase (ADA)
Treated organism Humans: adults
Indication(s) Severe combined immunodeficiency due to adenosine deaminase deficiency (ADA-SCID)
Administration route(s) Intravenous infusion
Type of authorisation Centralised at European level (orphan status)
Legal frame Council regulation (EC) No 726/2004 and the environmental safety requirements laid down by European Directive 2001/18/EC, part C and the Royal Decree of 21/02/2005, article 27
Competent authority EMA/European Commission
Belgian advisory body Biosafety Advisory Council
Date of the advices of the Biosafety Advisory Council 08/09/2015, 15/02/2016
EMA (CHMP) opinion (date) Positive (01/04/2016)
European Commission authorisation number (date) EU/1/16/1097 (26/05/2016)
European Commission decision Community register of medicinal products
European Public Assessment Report (including EMA opinion, Product information leaflet and Summary of product characteristics in all EU languages) EPAR (link to Web site of EMA)
Notifications to Belgian authorities while in Research and Development stage None

 

Kymriah
Application number EMEA/H/C/004090
Marketing authorisation holder Novartis Europharm Limited 
Name of the product Kymriah
Active substances Tisagenlecleucel, autologous T cells transduced with lentiviral vector containing a chimeric antigen receptor directed against CD19. 
Parental organism Autologous T cells 
Transgene(s) Chimeric antigen receptor directed against CD19 
Treated organism Humans: adults
Indication(s) Paediatric and young adult patients up to 25 years of age with B cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post transplant or in second or later relapse. Adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) after two or more lines of systemic therapy
Administration route(s) Intravenous infusion
Type of authorisation Centralised at European level (orphan status)
Legal frame Council regulation (EC) No 726/2004 and the environmental safety requirements laid down by European Directive 2001/18/EC, part C and the Royal Decree of 21/02/2005, article 27
Competent authority EMA/European Commission
Belgian advisory body Biosafety Advisory Council
Date of the advice of the Biosafety Advisory Council 01/03/2018, 18/05/2018
EMA (CHMP) opinion (date) Positive (28/06/2018)
European Commission authorisation number (date) EU/1/18/1297 (22/08/2018)
European Commission decision Community register of medicinal products
European Public Assessment Report (including EMA opinion, Product information leaflet and Summary of product characteristics in all EU languages) EPAR (link to Web site of EMA)
Notifications to Belgian authorities while in Research and Development stage None

 

Yescarta
Application number EMEA/H/C/004480
Marketing authorisation holder Kite Pharma EU B.V
Name of the product Yescarta
Active substances Axicabtagene ciloleucel, autologous T cells genetically modified to express a chimeric antigen receptor against CD19
Parental organism Autologous T cells
Transgene(s) Chimeric antigen receptor targeting CD19
Treated organism Humans: adults
Indication(s) Treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy
Administration route(s) Intravenous infusion
Type of authorisation Centralised at European level (orphan status)
Legal frame Council regulation (EC) No 726/2004 and the environmental safety requirements laid down by European Directive 2001/18/EC, part C and the Royal Decree of 21/02/2005, article 27
Competent authority EMA/European Commission
Belgian advisory body Biosafety Advisory Council
Date of the advice of the Biosafety Advisory Council 30/11/2017, 06/04/2018, 20/06/2018
EMA (CHMP) opinion (date) Positive (28/06/2018)
European Commission authorisation number (date) EU/1/18/1299 (23/08/2018)
European Commission decision Community register of medicinal products
European Public Assessment Report (including EMA opinion, Product information leaflet and Summary of product characteristics in all EU languages) EPAR (link to Web site of EMA)
Notifications to Belgian authorities while in Research and Development stage None

 

Luxturna
Application number EMEA/H/C/004451
Marketing authorisation holder Novartis Europharm Limited
Name of the product Luxturna
Active substances Voretigene neparvovec, recombinant adeno-associated virus serotype 2 harbouring the human retinal pigment epithelium protein gene (RPE 65
Parental organism Replication defective recombinant adeno-associated virus serotype 2 
Transgene(s) Human retinal pigment epithelium-specific 65 kDA protein gene (RPE65
Treated organism Humans: adult and paediatric patients
Indication(s) Treatment of adult and paediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells
Administration route(s) Subretinal injection 
Type of authorisation Centralised at European level (orphan status)
Legal frame Council regulation (EC) No 726/2004 and the environmental safety requirements laid down by European Directive 2001/18/EC, part C and the Royal Decree of 21/02/2005, article 27
Competent authority EMA/European Commission
Belgian advisory body Biosafety Advisory Council
Date of the advice of the Biosafety Advisory Council 27/11/2017, 30/04/2018, 11/07/2018
EMA (CHMP) opinion (date) Positive (20/09/2018)
European Commission authorisation number (date) EU/1/18/1331 (22/11/2018)
European Commission decision Community register of medicinal products
European Public Assessment Report (including EMA opinion, Product information leaflet and Summary of product characteristics in all EU languages) EPAR (link to Web site of EMA)
Notifications to Belgian authorities while in Research and Development stage None

 

Dengvaxia
Application number EMEA/H/C/004171
Marketing authorisation holder Sanofi Pasteur
Name of the product Dengvaxia
Active substances Dengue tetravalent vaccine (live, attenuated)
Parental organism Attenuated yellow fever vaccine strain 
Transgene(s) Each chimeric yellow fever dengue virus contains the prM and E genes from each of the dengue virus serotypes 1,2,3 and 4
Treated organism Humans: adults
Indication(s) Prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4 in individuals 9 to 45 years of age with prior dengue virus infection and living in endemic areas
Administration route(s) Subcutaneous route
Type of authorisation Centralised at European level (orphan status)
Legal frame Council regulation (EC) No 726/2004 and the environmental safety requirements laid down by European Directive 2001/18/EC, part C and the Royal Decree of 21/02/2005, article 27
Competent authority EMA/European Commission
Belgian advisory body Biosafety Advisory Council
Date of the advice of the Biosafety Advisory Council 24/05/2015, 31/01/2017, 31/03/2018
EMA (CHMP) opinion (date) Positive (18/10/2018)
European Commission authorisation number (date) EU/1/18/1338 (12/12/2018)
European Commission decision Community register of medicinal products
European Public Assessment Report (including EMA opinion, Product information leaflet and Summary of product characteristics in all EU languages) EPAR (link to Web site of EMA)
Notifications to Belgian authorities while in Research and Development stage None

 

Zynteglo
Application number EMA/H/C/003691
Marketing authorisation holder Bluebird bio (Netherlands) B.V.
Name of the product Zynteglo
Active substances Genetically modified stem cells transduced with third generation, type I HIV-based lentiviral vector encoding the gene for beta-globin
Parental organism Autologous CD34+ haematopoietic stem cells
Transgene(s) beta-A-T87Q-globin gene
Treated organism Humans: children (from 12 years) and adults
Indication(s) Treatment against transfusion-dependent β-thalassemia (TDT) or severe sickle cell disease (SCD)
Administration route(s) Intravenous infusion
Type of authorisation Centralised at European level (orphan status)
Legal frame Council regulation (EC) No 726/2004 and the environmental safety requirements laid down by European Directive 2001/18/EC, part C and the Royal Decree of 21/02/2005, article 27
Competent authority EMA/European Commission
Belgian advisory body Biosafety Advisory Council
Date of the advice of the Biosafety Advisory Council 14/01/2019, 15/03/2019
EMA (CHMP) opinion (date) Positive (29/03/2019)
European Commission authorisation number (date) EU/1/19/1367; EU/3/12/1091 (04/06/2019)
European Commission decision Community register of medicinal products
European Public Assessment Report (including EMA opinion, Product information leaflet and Summary of product characteristics in all EU languages) EPAR (link to Web site of EMA)
Notifications to Belgian authorities while in Research and Development stage None

 

Zolgensma
Application number EMEA/H/C/004750
Marketing authorisation holder Novartis Gene Therapies EU Limited
Name of the product Zolgensma
Active substances Onasemnogene abeparvovec
Parental organism Adeno-associated virus serotype 9
Transgene(s) Survival motor neuron gene (SMN1-2)
Treated organism Human: babies
Indication(s) Treatment against Spinal muscular atrophy (SMA)
Administration route(s) Intravenous infusion
Type of authorisation Centralised at European level (orphan status)
Legal frame Council regulation (EC) No 726/2004 and the environmental safety requirements laid down by European Directive 2001/18/EC, part C and the Royal Decree of 21/02/2005, article 27
Competent authority EMA/European Commission
Belgian advisory body Biosafety Advisory Council
Date of the advice of the Biosafety Advisory Council 08/02/2019, 11/06/2019
EMA (CHMP) opinion (date) Positive (27/03/2020)
European Commission authorisation number (date) EU/1/20/1443; EU/3/15/1509 (18/05/2020)
European Commission decision Community register of medicinal products
European Public Assessment Report (including EMA opinion, Product information leaflet and Summary of product characteristics in all EU languages) EPAR (link to Web site of EMA)
Notifications to Belgian authorities while in Research and Development stage B/BE/18/BVW6

 

Vaxchora
Application number EMEA/H/C/​003876
Marketing authorisation holder Emergent Netherlands B.V.
Name of the product Vaxchora
Active substances Vibrio cholerae, strain cvd 103-hgr, live
Parental organism CVD 103-HgR V. cholerae
Transgene(s) Vibrio cholerae in which 94% deletion of the genes encoding the A1 subunit of cholera toxin (CT)
Treated organism Humans: adult and paediatric patients
Indication(s) Vaccintation against cholera
Administration route(s) Oral
Type of authorisation Centralised at European level
Legal frame Council regulation (EC) No 726/2004 and the environmental safety requirements laid down by European Directive 2001/18/EC, part C and the Royal Decree of 21/02/2005, article 27
Competent authority EMA/European Commission
Belgian advisory body Biosafety Advisory Council
Date of the advice of the Biosafety Advisory Council 10/05/2019, 04/10/2019
EMA (CHMP) opinion (date) Positive (01/02/2020)
European Commission authorisation number (date) EU/1/20/1423 (01/04/2020)
European Commission decision Community register of medicinal products
European Public Assessment Report (including EMA opinion, Product information leaflet and Summary of product characteristics in all EU languages) EPAR (link to Web site of EMA)
Notifications to Belgian authorities while in Research and Development stage none

 

Ervebo
Application number EMEA/H/C/​004554
Marketing authorisation holder Merck Sharp & Dohme B.V.
Name of the product Ervebo
Active substances Recombinant vesicular stomatitis virus (strain indiana) with a deletion of the envelope glycoprotein, replaced with the zaire ebolavirus (strain kikwit 1995) surface glycoprotein
Parental organism Vesicular stomatitis virus
Transgene(s) A surface glycoprotein from Zaire Ebola virus
Treated organism Humans: adult
Indication(s) ​Vaccination against Ebola virus
Administration route(s) Injection
Type of authorisation Centralised at European level
Legal frame Council regulation (EC) No 726/2004 and the environmental safety requirements laid down by European Directive 2001/18/EC, part C and the Royal Decree of 21/02/2005, article 27
Competent authority EMA/European Commission
Belgian advisory body Biosafety Advisory Council
Date of the advice of the Biosafety Advisory Council 20/05/2019, 05/09/2019, 01/10/2019
EMA (CHMP) opinion (date) Positive (18/10/2019)
European Commission authorisation number (date) EU/1/19/1392 (11/11/2019)
European Commission decision Community register of medicinal products
European Public Assessment Report (including EMA opinion, Product information leaflet and Summary of product characteristics in all EU languages) EPAR (link to Web site of EMA)
Notifications to Belgian authorities while in Research and Development stage B/BE/19/BVW4

 

ZABDENO
Application number EMEA/H/C/005337
Marketing authorisation holder Janssen-Cilag International NV
Name of the product ZABDENO
Active substances Recombinant Adenovirus type 26 (Ad26) encoding the glycoprotein (GP) of the Ebola virus Zaire (ZEBOV) Mayinga strain
Parental organism Adenovirus type 26
Transgene(s) Glycoprotein (GP) of the Ebola virus Zaire
Treated organism Humans: adult and paediatric patients
Indication(s) ​Vaccination against Ebola virus
Administration route(s) Intramuscular injection
Type of authorisation Centralised at European level
Legal frame Council regulation (EC) No 726/2004 and the environmental safety requirements laid down by European Directive 2001/18/EC, part C and the Royal Decree of 21/02/2005, article 27
Competent authority EMA/European Commission
Belgian advisory body Biosafety Advisory Council
Date of the advice of the Biosafety Advisory Council 07/02/2020
EMA (CHMP) opinion (date) Positive (29/05/2020)
European Commission authorisation number (date) EU/1/20/1444 (01-07-2020)
European Commission decision Community register of medicinal products
European Public Assessment Report (including EMA opinion, Product information leaflet and Summary of product characteristics in all EU languages) EPAR (link to Web site of EMA)
Notifications to Belgian authorities while in Research and Development stage none

 

MVABEA
Application number EMEA/H/C/005343
Marketing authorisation holder Janssen-Cilag International NV
Name of the product MVABEA
Active substances Recombinant Modified Vaccinia Ankara Bavarian Nordic Virus encoding the: Ebola virus Zaire (ZEBOV) Mayinga strain glycoprotein (GP); Ebola virus Sudan Gulu strain GP; Ebola virus Taï Forest strain nucleoprotein and the Marburg virus Musoke strain GP
Parental organism Modified Vaccinia Ankara (MVA) virus
Transgene(s) Glycoprotein (GP) of EBOV, Sudan ebolavirus (SUDV), and Marburg Marburgvirus (MARV), as well as the nucleoprotein (NP) of the Taï Forest ebolavirus (TAFV).
Treated organism Humans: adult and paediatric patients
Indication(s) ​Vaccination against Ebola virus
Administration route(s) Intramuscular injection
Type of authorisation Centralised at European level
Legal frame Council regulation (EC) No 726/2004 and the environmental safety requirements laid down by European Directive 2001/18/EC, part C and the Royal Decree of 21/02/2005, article 27
Competent authority EMA/European Commission
Belgian advisory body Biosafety Advisory Council
Date of the advice of the Biosafety Advisory Council 07/02/2020
EMA (CHMP) opinion (date) Positive (29/05/2020)
European Commission authorisation number (date) EU/1/20/1445 (01-07-2020)
European Commission decision Community register of medicinal products
European Public Assessment Report (including EMA opinion, Product information leaflet and Summary of product characteristics in all EU languages) EPAR (link to Web site of EMA)
Notifications to Belgian authorities while in Research and Development stage none

 

Libmeldy
Application number ​EMEA/H/C/005321
Marketing authorisation holder Orchard Therapeutics (Netherlands) B.V.
Name of the product Libmeldy
Active substances GM CD34+ stem cell containing a copy of the ARSA gene
Parental organism Autologous CD34+ cells
Transgene(s) Human arylsulfatase A (ARSA) gene
Treated organism Humans: adult and paediatric patients
Indication(s) ​Treatment against metachromatic leukodystrophy (MLD)​​
Administration route(s) Intravenous infusion
Type of authorisation Centralised at European level (orphan status)
Legal frame Council regulation (EC) No 726/2004 and the environmental safety requirements laid down by European Directive 2001/18/EC, part C and the Royal Decree of 21/02/2005, article 27
Competent authority EMA/European Commission
Belgian advisory body Biosafety Advisory Council
Date of the advice of the Biosafety Advisory Council 06/03/2020
EMA (CHMP) opinion (date) Positive (16/10/2020)
European Commission authorisation number (date) EU/1/20/1493, EU/3/07/446, 17-12-2020
European Commission decision Community register of medicinal products
European Public Assessment Report (including EMA opinion, Product information leaflet and Summary of product characteristics in all EU languages) EPAR (link to Web site of EMA)
Notifications to Belgian authorities while in Research and Development stage none

 

Abecma
Application number ​​EMEA/H/C/004662
Marketing authorisation holder Bristol-Myers Squibb Pharma EEIG
Name of the product Abecma
Active substances Idecabtagene vicleucel, genetically modified T cells transduced with third generation, type I HIV-based lentiviral vector encoding an anti-BCMA02 antigen
Parental organism Autologous T lymphocyte cells
Transgene(s) Chimeric antigen receptor (CAR) targeting the BCMA expression on myeloma cells
Treated organism Humans: adult
Indication(s) ​Treatment against relapsed and refractory multiple myeloma​​
Administration route(s) Intravenous infusion
Type of authorisation Centralised at European level (orphan status)
Legal frame Council regulation (EC) No 726/2004 and the environmental safety requirements laid down by European Directive 2001/18/EC, part C and the Royal Decree of 21/02/2005, article 27
Competent authority EMA/European Commission
Belgian advisory body Biosafety Advisory Council
Date of the advice of the Biosafety Advisory Council 04/09/2020
EMA (CHMP) opinion (date) Positive (25/06/2021)
European Commission authorisation number (date) EU/1/21/1539, EU/3/17/1863 (18-08-2021)
European Commission decision Community register of medicinal products
European Public Assessment Report (including EMA opinion, Product information leaflet and Summary of product characteristics in all EU languages) EPAR (link to Web site of EMA)
Notifications to Belgian authorities while in Research and Development stage none

 

Breyanzi
Application number ​​​EMEA/H/C/004731
Marketing authorisation holder Bristol-Myers Squibb Pharma EEIG
Name of the product Breyanzi
Active substances Lisocabtagene maraleucel, genetically modified T cells transduced with third generation, type I HIV-based lentiviral vector encoding the gene CD19
Parental organism Autologous CD8+ and CD4+ T cell
Transgene(s) Chimeric antigen receptor (CAR) targeting CD19-expressing cells
Treated organism Humans: adult
Indication(s) Treatment against relapsed or refractory large B cell lymphoma​​
Administration route(s) Intravenous infusion
Type of authorisation Centralised at European level (orphan status)- Orphan designation withdrawal : 20/05/2022
Legal frame Council regulation (EC) No 726/2004 and the environmental safety requirements laid down by European Directive 2001/18/EC, part C and the Royal Decree of 21/02/2005, article 27
Competent authority EMA/European Commission
Belgian advisory body Biosafety Advisory Council
Date of the advice of the Biosafety Advisory Council 28/10/2020
EMA (CHMP) opinion (date) Positive (28/01/2022)
European Commission authorisation number (date) EU/1/22/1631 (04-04-2022)
European Commission decision Community register of medicinal products
European Public Assessment Report (including EMA opinion, Product information leaflet and Summary of product characteristics in all EU languages) EPAR (link to Web site of EMA)
Notifications to Belgian authorities while in Research and Development stage none

 

Ad26_COV2_S COVID-19 Vaccine Janssen
Application number ​​​EMEA/H/C/005737
Marketing authorisation holder Janssen-Cilag International NV
Name of the product Ad26_COV2_S COVID-19 Vaccine Janssen
Active substances Recombinant Adenovirus type 26
Parental organism Adenovirus type 26 (Ad26)
Transgene(s) Modified SARS-CoV-2 S protein
Treated organism Humans: adult
Indication(s) Vaccination against COVID-19 virus
Administration route(s) Intramuscular injection
Type of authorisation Centralised at European level
Legal frame Council regulation (EC) No 726/2004 and the environmental safety requirements laid down by European Directive 2001/18/EC, part C and the Royal Decree of 21/02/2005, article 27
Competent authority EMA/European Commission
Belgian advisory body Biosafety Advisory Council
Date of the advice of the Biosafety Advisory Council 05/01/2021
EMA (CHMP) opinion (date) Positive (11/03/2021)
European Commission authorisation number (date) EU/1/20/1525 (11-03-2021)
European Commission decision Community register of medicinal products
European Public Assessment Report (including EMA opinion, Product information leaflet and Summary of product characteristics in all EU languages) EPAR (link to Web site of EMA)
Notifications to Belgian authorities while in Research and Development stage none

 

Skysona
Application number EMEA/H/C/003690
Marketing authorisation holder bluebird bio (Netherlands) B.V.
Name of the product Skysona
Active substances elivaldogene autotemcel, genetically modified stem cells enriched to express the human adrenoleukodystrophy protein (ALDP)
Parental organism Autologous T lymphocyte cells
Transgene(s) Human adrenoleukodystrophy protein (ALDP)
Treated organism Humans: paediatric patients
Indication(s) Treatment against childhood cerebral adrenoleukodystrophy​
Administration route(s) Intravenous infusion
Type of authorisation Centralised at European level (orphan status ended on 19-Nov-21)
Legal frame Council regulation (EC) No 726/2004 and the environmental safety requirements laid down by European Directive 2001/18/EC, part C and the Royal Decree of 21/02/2005, article 27
Competent authority EMA/European Commission
Belgian advisory body Biosafety Advisory Council
Date of the advice of the Biosafety Advisory Council 08/01/2021
EMA (CHMP) opinion (date) Positive (21/05/2021)
European Commission authorisation number (date) EU/1/21/1563, EU/3/12/1003, Autorisation on 16-07-2021, Withdrawal on 18-11-2021
European Commission decision Community register of medicinal products
European Public Assessment Report (including EMA opinion, Product information leaflet and Summary of product characteristics in all EU languages) EPAR (link to Web site of EMA)
Notifications to Belgian authorities while in Research and Development stage none

 

Vaxzevria (Astrazeneca)
Application number EMEA/H/C/005675
Marketing authorisation holder AstraZeneca AB
Name of the product Vaxzevria (Astrazeneca)
Active substances Recombinant, replication-deficient chimpanzee adenovirus (ChAdOx1)
Parental organism Chimpanzee adenovirus
Transgene(s) Spike (S) glycoprotein of severe acute respiratory syndrome-coronavirus-2 (SARS CoV-2)
Treated organism Humans: adult
Indication(s) Vaccination against COVID-19 virus
Administration route(s) Intramuscular injection
Type of authorisation Centralised at European level
Legal frame Council regulation (EC) No 726/2004 and the environmental safety requirements laid down by European Directive 2001/18/EC, part C and the Royal Decree of 21/02/2005, article 27
Competent authority EMA/European Commission
Belgian advisory body Biosafety Advisory Council
Date of the advice of the Biosafety Advisory Council 13/01/2021
EMA (CHMP) opinion (date) Positive (29/01/2021)
European Commission authorisation number (date) EU/1/21/1529 (29-01-2021)
European Commission decision Community register of medicinal products
European Public Assessment Report (including EMA opinion, Product information leaflet and Summary of product characteristics in all EU languages) EPAR (link to Web site of EMA)
Notifications to Belgian authorities while in Research and Development stage B/BE/20/BVW2

 

Carvykti
Application number EMEA/H/C/005095
Marketing authorisation holder Janssen-Cilag International NV
Name of the product Carvykti
Active substances Ciltacabtagene autoleucel, genetically modified T cells transduced with third generation, type I HIV-based lentiviral vector encoding an anti-B-cell maturation antigen
Parental organism Autologous CD8+ and CD4+ T cell
Transgene(s) Chimeric antigen receptor (CAR) targeting B- cell maturation antigen (BCMA)
Treated organism Humans: adult
Indication(s) Cancer immocellular therapy against relapsed or refractory multiple myeloma
Administration route(s) Intravenous infusion
Type of authorisation Centralised at European level (orphan status)
Legal frame Council regulation (EC) No 726/2004 and the environmental safety requirements laid down by European Directive 2001/18/EC, part C and the Royal Decree of 21/02/2005, article 27
Competent authority EMA/European Commission
Belgian advisory body Biosafety Advisory Council
Date of the advice of the Biosafety Advisory Council 30/08/2021
EMA (CHMP) opinion (date) Positive (24/03/2022)
European Commission authorisation number (date) EU/3/22/1648 (30-05-2022)
European Commission decision Community register of medicinal products
European Public Assessment Report (including EMA opinion, Product information leaflet and Summary of product characteristics in all EU languages) EPAR (link to Web site of EMA)
Notifications to Belgian authorities while in Research and Development stage none