Marketing authorisations for GMO-medicinal products for veterinary use

Up to now, nineteen GMO medicinal products for veterinary use have been granted a marketing authorisation in the EU. Eighteen of these products are vaccines, one is a treatment against cancer (Oncept IL-2).
Two of them were authorised under Directive 90/220/EEC:

  • A vaccine against the porcine Aujeszky disease (genetically modified virus), authorised in December 1992 (authorisation amended in July 1994 – Decision 94/505/EC – to cover a new form of administration);
  • The Raboral recombinant vaccine for preventing rabies in foxes (see text box on the right), authorised in October 1993 (Decision 93/572/EEC).

The other products have been processed under Regulation (EEC) No. 2309/93 (between 1993 and 2004) or Regulation (EC) 726/2004.

All these GMO medicinal products for veterinary use are listed below in alphabetical order with the corresponding date of authorisation. For more details on the product and the authorisation procedure click on the corresponding link.

 

Bovela
Application number EMEA/V/C/003703
Marketing authorisation holder Boehringer ingelheim International GmbH
Name of the product Bovela
Active substances Live double gene deleted bovine viral diarrhoea virus type 1 (strain ke-9) Live double gene deleted bovine viral diarrhoea virus type 2 (strain ny-93)
Parental organism Bovine viral diarrhoea virus - BVD-1 and BVD-2
Transgene(s) -
Treated organism Cattle
Indication(s) Vaccination of cattle against Bovine viral diarrhoea virus (BVD-1 and BVD-2E)
Administration route(s) Intramuscular
Type of authorisation Centralised at european level
Legal framework Council regulation (EEC) 2309/93 and the environmental safety requirements laid down by European Directive 90/220/EEC, part C and the Royal Decree of 18/12/1998, article 22
Competent authority EMEA/European Commission
Belgian advisory body Biosafety Advisory Council
Date of the advice of the Biosafety Advisory Council No advice
EMEA (CVMP) opinion (date) Positive (09/10/2014)
European Commission authorisation number (date) EU/2/14/176 (22/12/2014)
European Commission decision Community register of medicinal products
European Public Assessment Report (including EMEA opinion, Product information leaflet and Summary of product characteristics in all EU languages) EPAR (link to EMA website)
Notifications to Belgian authorities while in Research and Development stage None

 

Equilis StrepE
Application number EMEA/V/C/078
Marketing authorisation holder Intervet International bv
Name of the product Equilis StrepE
Active substances Live recombinant Streptococcus equi strain TW928 deletion mutant
Parental organism Streptococcus equi virus strain TW928
Transgene(s) Deletion mutant strain TW928 of Streptococcus equi
Treated organism Horses
Indication(s) Active immunisation of horses of 4 months of age or older against Streptococcus equi infection (strangles) to reduce clinical signs and occurence of lymph node abscesses.
Administration route(s) Submucodally into the inside of the upper lip
Type of authorisation Centralised at european level
Legal frame Council regulation (EEC) 2309/93 and the environmental safety requirements laid down by European Directive 90/220/EEC, part C and the Royal Decree of 18/12/1998, article 22
Competent authority EMEA/European Commission
Belgian advisory body Biosafety Advisory Council
Date of the meeting of the Biosafety Advisory Council 03/02/2003
EMEA (CVMP) opinion (date) Positive (10/02/2004)
European Commission authorisation number (date) EU/2/04/043/001 (07/05/2004)
European Commission decision Community register of Medicinal products
European Public Assessment Report (including EMEA opinion, Product information leaflet and Summary of product characteristics in all EU languages) EPAR (link to EMA website)
Notifications to Belgian authorities while in Research and Development stage None

 

Hiprabovis IBR Marker Live
Application number EMEA/V/C/000158
Marketing authorisation holder Laboratorios HIPRA S.A.
Name of the product Hiprabovis IBR Marker Live
Active substances Live gE- tk- double-gene deleted Bovine Herpes Virus type 1 (BoHv-1), strain CEDDEL
Parental organism Bovine Herpes Virus
Transgene(s) Double deleted strain of IBR (strain CEDDEL) - deletion of regions of the virus genome that cpde for glycoprotein E (gE) and for the enzyme thymidine kinase (tk)
Treated organism Cattle
Indication(s) Vaccination of cattle (cows and calves) against respiratory infections caused by infectious bovine rhinotracheitis (IBR)
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 advice of the Biosafety Advisory Council 15/06/2009
EMA (CVMP) opinion (date) Positive 13/11/2010)
European Commission authorisation number (date) EU/2/10/114 (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 EMA Web site)
Notifications to Belgian authorities while in Research and Development stage None

 

Innovax-ILT
Application number EMEA/V/C/003869
Marketing authorisation holder Intervet International
Name of the product Innovax-ILT
Active substances Live recombinant turkey herpesvirus (strain HVT/ILT-138)
Parental organism Turkey herpesvirus
Transgene(s) Glycoproteins gD and gI of infectious laryngotracheitis virus
Treated organism Chickens
Indication(s) Vaccination of chickens against Marek's disease and Infectious Laryngotracheitis
Administration route(s) Subcutaneous
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 10/06/2014, 03/03/2015, 17/04/2015
EMA (CVMP) opinion (date) Positive (07/05/2015)
European Commission authorisation number (date) EU/2/15/182 (03/07/2015)
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 EMA website)
Notifications to Belgian authorities while in Research and Development stage None

 

Nobivac Myxo-RHD
Application number EMEA/V/C/002004
Marketing authorisation holder Intervet International
Name of the product Nobivac Myxo-RHD
Active substances Live attenuated Myxoma virus strain
Parental organism Myxoma virus
Transgene(s) Myxoma virus strain expressing the capsid protein gene of rabbit haemorrhagic disease
Treated organism Rabbits
Indication(s) Vaccination of rabbits against myxomatose and haemorrhagic disease
Administration route(s) Subcutaneous
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 17/05/2010
EMA (CVMP) opinion (date) Positive (14/07/2011)
European Commission authorisation number (date) EU/2/11/132/ (07/09/2011)
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 EMA Web site)
Notifications to Belgian authorities while in Research and Development stage None

 

Nobi-Porvac Aujeszky
Application number Not available
Marketing authorisation holder Vemie Veterinär Chemie Gmbh, Germany
Name of the product Nobi-Porvac Aujeszky live (gl, tk) (with Diluvac forte)
Active substances Live attenuated Aujeszky's Disease Virus, strain Begonia
Parental organism Aujeszky's Disease Virus, strain Begonia
Transgene(s) 2 genes of the virus have been deleted : glycoprotein gene and thymidine kinase gene
Treated organism Pigs
Indication(s) Immunisation of pigs against Aujeszky disease
Administration route(s) Intramuscular or intra-dermal
Type of authorisation Centralised at european level
Legal frame European Directive 90/220/EEC, part C
Competent authority European Commission
Belgian advisory body Not applicable
EMEA (CVMP) opinion Not applicable
European Commission authorisation number (date) C/D/92/I-1 (18/12/1992 for intramuscular) and 31994D0505 (18/07/1994 for intra-dermal)
European Commission decision Decision 94/505/EC (link to the Eur-lex website)
European Public Assessment Report Not available
Product information leaflet Not available
Summary of product characteristics Not available
Notifications to Belgian authorities while in Research and Development stage Not applicable

 

Oncept IL-2
Application number EMEA/V/C/002562
Marketing authorisation holder Merial
Name of the product Oncept IL-2
Active substances Feline interleukine-2 recombinant canarypox virus (VCP1338 virus)
Parental organism Live attenuated canrypox virus (clone ALVAC)
Transgene(s) Feline gene coding for interleukin-2
Treated organism Cats
Indication(s) Fibrosarcoma
Administration route(s) Subcutaneous
Type of authorisation Centralised at European level
Legal frame Council regulation (EEC) 2309/93 and the environmental safety requirements laid down by European Directive 90/220/EEC, part C and the Royal Decree of 18/12/1998, article 22
Competent authority EMA/European Commission
Belgian advisory body Biosafety Advisory Council
Date of the advice of the Biosafety Advisory Council 07/02/2012 and 26/10/2012
EMA (CVMP) opinion (date) Positive (07/03/2013)
European Commission authorisation number (date) EU/2/13/150 (03/05/2013)
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 EMA Web site)
Notifications to Belgian authorities while in Research and Development stage None

 

Poulvac E. coli
Application number EMEA/V/C/002007
Marketing authorisation holder Pfizer Ltd
Name of the product Poulvac E. coli
Active substances Live aroA gene deleted Escherichia coli, type O78
Parental organism Escherichia coli
Transgene(s) -
Treated organism Chickens
Indication(s) Vaccination of chickens against E. coli O78
Administration route(s) Coarse spray
Type of authorisation Centralised at european level
Legal frame Council regulation (EEC) 2309/93 and the environmental safety requirements laid down by European Directive 90/220/EEC, part C and the Royal Decree of 18/12/1998, article 22
Competent authority EMA/European Commission
Belgian advisory body Biosafety Advisory Council
Date of the advice of the Biosafety Advisory Council 09/05/2011
EMA (CVMP) opinion (date) Positive (13/04/2012)
European Commission authorisation number (date) EU/2/12/140 (15/06/2012)
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 EMA Web site)
Notifications to Belgian authorities while in Research and Development stage None

 

ProteqFLU
Application number EMEA/V/C/073
Marketing authorisation holder MERIAL, France
Name of the product ProteqFLU
Active substances Live recombinant canarypox viruses expressing the haemagglutin HA gene from the equine influenza virus strains A/equi-2/Kentucky/94 (USA representative) and A/equi-2/Newmarket/293 (European representative).
Parental organism Canarypox virus
Transgene(s) Haemagglutin HA gene from the equine influenza virus strains A/equi-2/Kentucky/94 (American strain) and A/equi-2/Newmarket/2/93 (European strain)
Treated organism Horses
Indication(s) Active immunisation of horses of 4 months of age or older against equine influenza to reduce clinical signs and virus excretion after infection.
Administration route(s) Intramuscular
Type of authorisation Centralised at european level
Legal frame Council regulation (EEC) 2309/93 and the environmental safety requirements laid down by European Directive 90/220/EEC, part C and the Royal Decree of 18/12/1998, article 22
Competent authority EMEA/European Commission
Belgian advisory body Biosafety Advisory Council
Date of the meeting of the Biosafety Advisory Council 04/02/2002
EMEA (CVMP) opinion (date) Positive (13/11/2002)
European Commission authorisation number (date) EU/2/03/037/001-2-3-4 (06/03/2003)
European Commission decision Community register of medicinal products
European Public Assessment Report (including EMEA opinion, Product information leaflet and Summary of product characteristics in all EU languages) EPAR (link to EMEA Web site)
Notifications to Belgian authorities while in Research and Development stage Not applicable

 

ProteqFLU-Te
Application number EMEA/V/C/074
Marketing authorisation holder MERIAL, France
Name of the product ProteqFLU-Te
Active substances Live recombinant canarypox viruses expressing the haemagglutin HA gene from the equine influenza virus strains A/equi-2/Kentucky/94 (USA representative) and A/equi-2/Newmarket/293 (European representative) + tetanus toxoid.
Parental organism Canarypox virus
Transgene(s) Haemagglutin HA gene from the equine influenza virus strains A/equi-2/Kentucky/94 (American strain) and A/equi-2/Newmarket/2/93 (European strain)
Treated organism Horses
Indication(s) Active immunisation of horses of 4 months of age or older against equine influenza to reduce clinical signs and virus excretion after infection and against tetanus to prevent mortality.
Administration route(s) Intramuscular
Type of authorisation Centralised at european level
Legal frame Council regulation (EEC) 2309/93 and the environmental safety requirements laid down by European Directive 90/220/EEC, part C and the Royal Decree of 18/12/1998, article 22
Competent authority EMEA/European Commission
Belgian advisory body Biosafety Advisory Council
Date of the meeting of the Biosafety Advisory Council 04/02/2002
EMEA (CVMP) opinion (date) Positive (13/11/2002)
European Commission authorisation number (date) EU/2/03/038/001-2-3-4 (06/03/2003)
European Commission decision Community register of medicinal products
European Public Assessment Report (including EMEA opinion, Product information leaflet and Summary of product characteristics in all EU languages) EPAR (link to EMEA Web site)
Notifications to Belgian authorities while in Research and Development stage B/BE/00/V15

 

Proteq WestNile
Application number EMEA/V/C/002005
Marketing authorisation holder Merial
Name of the product Proteq WestNile
Active substances Live attenuated recombinant canarypox virus
Parental organism Canarypox virus
Transgene(s) Canarypox virus expressing the preM and E genes of West Nile virus
Treated organism Horses
Indication(s) Vaccination of horses against West Nile virus fever
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 advice of the Biosafety Advisory Council 26/08/2010 ; 08/04/2011
EMA (CVMP) opinion (date) Positive (09/06/2011)
European Commission authorisation number (date) EU/2/11/129/ (05/08/2011)
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 EMA Web site)
Notifications to Belgian authorities while in Research and Development stage None

 

Purevax FeLV (formerly Eurifel FeLV)
Application number EMEA/V/C/056/01/0/0
Marketing authorisation holder MERIAL, France
Name of the product Purevax FeLV (formerly Eurifel FeLV)
Active substances Canarypoxvirus (ALVAC), the genome of which contains the env and gag genes and part of the pol gene of the subgroup A of the FeLV virus (strain vCP97).
Parental organism Canarypox virus
Transgene(s) Env and gag genes and part of the pol gene of the subgroup A of the FeLV virus (strain vCP97)
Treated organism Cats
Indication(s) Active immunisation of cats of 8 weeks of age or older against feline leukaemia for the prevention of persistent viraemia and clinical manifestations of the disease.
Administration route(s) Subcutaneous
Type of authorisation Centralised at european level
Legal frame Council regulation (EEC) 2309/93 and the environmental safety requirements laid down by European Directive 90/220/EEC, part C and the Royal Decree of 18/12/1998, article 22
Competent authority EMEA/European Commission
Belgian advisory body Biosafety Advisory Council
Date of the meeting of the Biosafety Advisory Council 18/03/1999
EMEA (CVMP) opinion (date) Positive (08/12/1999)
European Commission authorisation number (date) EU/2/00/019/001-002-003-004 (13/04/2000)
European Commission decision Community register of medicinal products
European Public Assessment Report (including EMEA opinion, Product information leaflet and Summary of product characteristics in all EU languages) EPAR (link to EMEA Web site)
Notifications to Belgian authorities while in Research and Development stage B/BE/99/VW8

 

Purevax rabies
Application number EMEA/V/C/002003
Marketing authorisation holder Merial
Name of the product Purevax rabies
Active substances Rabies recombinant canarypox virus
Parental organism Canarypox virus
Transgene(s) Canarypox virus expressing the surface glycoprotein G gene from Rabies virus, called VCP65
Treated organism Cats
Indication(s) Vaccination of cats against rabies
Administration route(s) Subcutaneous
Type of authorisation Centralised at European level
Legal frame Council regulation (EC) No 726/2004 (full text in English) 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 15/03/2010 ; 28/10/2010
EMA (CVMP) opinion (date) Positive (08/12/2010)
European Commission authorisation number (date) EU/2/10/117/ (18/02/2011)
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 EMA Web site)
Notifications to Belgian authorities while in Research and Development stage None

 

Purevax RCP FeLV (formerly Eurifel RCP FeLV) 
Application number EMEA/V/C/067/01/0/0
Marketing authorisation holder MERIAL, France
Name of the product Eurifel RCPFeLV
Active substances FeLV (vCP97) recombinant canarypox virus = same as in Eurifel FeLV + attenuated feline panleucopenia virus (PLI IV), type 1 feline herpesvirus antigen (C27), feline calcivirus antigen (FCV255)
Parental organism Canarypox virus
Transgene(s) Env and gag genes and part of the pol gene of the subgroup A of the FeLV virus (strain vCP97)
Treated organism Cats
Indication(s) Active immunisation of cats of 8 weeks of age or older against feline infectious rhinotracheitis and calcivirus infection to reduce clinical signs and viral excretion; againts feline panleucopenia to prevent mortality and reduce clinical signs; and against feline leukaemia to prevent persistent viraemia and reduce clinical signs of the disease.
Administration route(s) Subcutaneous
Type of authorisation Centralised at european level
Legal frame Council regulation (EEC) 2309/93 and the environmental safety requirements laid down by European Directive 90/220/EEC, part C and the Royal Decree of 18/12/1998, article 22
Competent authority EMEA/European Commission
Belgian advisory body Biosafety Advisory Council
Date of the meeting of the Biosafety Advisory Council No meeting (same GMO as in Eurifel FeLV)
EMEA (CVMP) opinion (date) Positive (05/12/2001)
European Commission authorisation number (date) EU/2/02/031/001-2 (08/03/2002)
European Commission decision Withdrawn from use in the European Union on 29/05/2007 (no renewal was requested)
European Public Assessment Report (including EMEA opinion, Product information leaflet and Summary of product characteristics in all EU languages) EPAR (link to EMEA Web site)
Notifications to Belgian authorities while in Research and Development stage Not applicable

 

Raboral V-RG
Application number C/B/92/B28 and C/F/93/03-02
Marketing authorisation holder Rhône-Mérieux
Name of the product Raboral V-RG
Active substances Vaccinia virus expressing glycoprotein G of the rabies virus
Parental organism Vaccinia virus, Copenhagen strain
Transgene(s) Gene expressing glycoprotein G of the rabies virus
Treated organism Foxes
Indication(s) Oral live anti-rabies vaccine for foxes, to be administered in bait
Administration route(s) Bait, oral
Type of authorisation Centralised at european level
Legal frame European Directive 90/220/EEC, part C
Competent authority European Commission
Belgian advisory body Institute of Public Health
EMEA (CVMP) opinion Not applicable
CVMP opinion date Not applicable
European Commission authorisation number (date) 91993D0572 (19/10/1993)
European Commission decision Decision 93/572/EEC (link to Eur-lex website)
European Public assessment report Not available
Product information leaflet Not available
Summary of product characteristics Not available
Notifications to Belgian authorities while in Research and Development stage Not applicable

 

Suvaxyn Aujeszky
Application number Not available
Marketing authorisation holder Fort Dodge Animal Health Holland
Name of the product Suvaxyn Aujeszky 783 + O/W
Active substances Live attenuated Aujeszky's Disease Virus, strain NIA3-783
Parental organism Aujeszky's Disease Virus, strain NIA3-783
Transgene(s) 2 genes of the virus have been deleted : thymidine kinase gene and glycoprotein E gene
Treated organism Pigs
Indication(s) Active immunisation of pigs of 10 weeks of age to prevent the mortality and clinical signs of Aujeszky's Disease and to reduce the excretion of Aujeszky's Disease field virus. Passive immunisation of the progeny of vaccinated gilts and sows to reduce mortality and clinical signs of Aujeszky's Disease and to reduce the excretion of Aujeszky's Disease field virus.
Administration route(s) Intramuscular
Type of authorisation Centralised at european level
Legal frame

Council regulation (EEC) 2309/93 and the environmental safety requirements laid down by European Directive 90/220/EEC, part C

Competent authority European Commission
Belgian advisory body Not applicable
EMEA (CVMP) opinion (date) Positive (08/12/1999)
European Commission authorisation number (date) EU/2/98/009/001-006 (07/08/1998)
European Commission decision Community register of medicinal products
European Public Assessment Report (including EMEA opinion, Product information leaflet and Summary of product characteristics in all EU languages) EPAR (link to EMEA Web site)
Notifications to Belgian authorities while in Research and Development stage Not applicable

 

Suvaxyn CSF Marker
Application number EMEA/V/C/002757
Marketing authorisation holder Zoetis Belgium S.A.
Name of the product Suvaxyn CSF Markerovela
Active substances Live recombinant E2 gene deleted Bovine Viral Diarrhoea Virus containing Classical Swine Fever E2 (CP7-E2alf)
Parental organism Bovine viral diarrhoea virus
Transgene(s) Classical Swine Fever E2
Treated organism Pigs
Indication(s) Vaccination of pigs against Classical Swine Fever virus
Administration route(s) Intramuscular
Type of authorisation Centralised at european level
Legal frame Council regulation (EEC) 2309/93 and the environmental safety requirements laid down by European Directive 90/220/EEC, part C and the Royal Decree of 18/12/1998, article 22
Competent authority EMA/European Commission
Belgian advisory body Biosafety Advisory Council
Date of the advice of the Biosafety Advisory Council none
EMA (CVMP) opinion (date) Positive (11/12/2014)
European Commission authorisation number (date) EU/2/14/179 (10/02/2015)
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 EMA Web site)
Notifications to Belgian authorities while in Research and Development stage None

 

Vaxxitek HVT + IBD (formerly Gallivac HVT IBD)
Application number EMEA/V/C/065
Marketing authorisation holder MERIAL, France
Name of the product Vaxxitek HVT + IBD (Gallivac HVT IBD)
Active substances Live vHVT013-69 virus (= recombinant Herpesvirus of turkeys)
Parental organism Herpesvirus of turkeys (HVT) FC-126 strain
Transgene(s) VP2 gene of the Infectious Bursal Disease Virus (IBDV) strain Faragher 52/70
Treated organism Chickens
Indication(s) Active immunisation of day-old chickens: to prevent mortality and reduce clinical signs and lesions of infectious Bursal disease; to reduce mortality, clinical signs and lesions of Marek's disease.
Administration route(s) Subcutaneous
Type of authorisation Centralised at european level
Legal frame Council regulation (EEC) 2309/93 and the environmental safety requirements laid down by European Directive 90/220/EEC, part C and the Royal Decree of 18/12/1998, article 22
Competent authority EMEA/European Commission
Belgian advisory body Biosafety Advisory Council
Date of the meeting of the Biosafety Advisory Council 05/10/2000
EMEA (CVMP) opinion (date) Positive (17/04/2002)
European Commission authorisation number (date) EU/2/02/032/001 (09/08/2002)
European Commission decision Community register of medicinal products
European Public Assessment Report (including EMEA opinion, Product information leaflet and Summary of product characteristics in all EU languages) EPAR (link to EMEA Web site)
Notifications to Belgian authorities while in Research and Development stage Not applicable

 

Vectormune ND
Application number EMEA/V/C/003829
Marketing authorisation holder CEVA-Phylaxia Co. Ltd.
Name of the product Vectormune ND
Active substances Live recombinant turkey herpes virus (rHVT/ND)
Parental organism Turkey herpes virus
Transgene(s) Fusion protein of Newcastle diseases virus D-26 lentogenic strain
Treated organism Chickens
Indication(s) Vaccination of chickens against Newcastle disease and Marek's disease
Administration route(s) Subcutaneous
Type of authorisation Centralised at european level
Legal framework Council regulation (EEC) 2309/93 and the environmental safety requirements laid down by European Directive 90/220/EEC, part C and the Royal Decree of 18/12/1998, article 22
Competent authority EMEA/European Commission
Belgian advisory body Biosafety Advisory Council
Date of the advice of the Biosafety Advisory Council 11/08/2014, 27/04/2015
EMEA (CVMP) opinion (date) Positive (10/07/2015)
European Commission authorisation number (date) EU/2/15/188 (08/09/2015)
European Commission decision Community register of medicinal products
European Public Assessment Report (including EMEA opinion, Product information leaflet and Summary of product characteristics in all EU languages) EPAR (link to EMA website)
Notifications to Belgian authorities while in Research and Development stage None