| 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) | Submucosally 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 |
| Prevexxion RN | |
|---|---|
| Application number | EMEA/V/C/005057 |
| Marketing authorisation holder | Boehringer Ingelheim Vetmedica GmbH |
| Name of the product | Prevexxion RN |
| Active substances | Live recombinant Marek’s disease (MD) virus, serotype 1, strain RN1250 |
| Parental organism | Attenuated Marek’s disease virus (MDV) CVI988 parental vaccine virus |
| Transgene(s) | / |
| Treated organism | Chickens |
| Indication(s) | Vaccination against Marek's disease |
| Administration route(s) | Subcutaneous 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 | 18/03/2019 |
| EMA (CHMP) opinion (date) | Positive (25-05-2020) |
| European Commission authorisation number (date) | EU/2/20/254 (20/07/2020) |
| 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 |
| Prevexxion RN HVT IBD | |
|---|---|
| Application number | EMEA/V/C/005058 |
| Marketing authorisation holder | Boehringer Ingelheim Vetmedica GmbH |
| Name of the product | Prevexxion RN HVT IBD |
| Active substances | Two live recombinant Marek’s disease virus, serotype 1, strain RN1250 and live recombinant turkey herpesvirus, expressing the VP2 protein of infectious bursal disease virus, strain vHVT013-69 |
| Parental organism | Attenuated Marek’s disease virus (MDV) CVI988 parental vaccine virus and recombinant turkey Herpesvirus (HVT) |
| Transgene(s) | VP2 protein of infectious bursal disease (IBD) virus |
| Treated organism | One-day-old Chickens |
| Indication(s) | Vaccination against Marek's and IBD Gumboro's diseases |
| Administration route(s) | Subcutaneous 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 | 18/03/2019 |
| EMA (CHMP) opinion (date) | Positive (25-05-2020) |
| European Commission authorisation number (date) | EU/2/20/255 (20/07/2020) |
| 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 |
| Vectormune FP ILT + AE | |
|---|---|
| Application number | EMEA/V/C/005077 |
| Marketing authorisation holder | CEVA-Phylaxia Co. Ltd. |
| Name of the product | Vectormune FP ILT + AE |
| Active substances | Live recombinant fowlpox virus expressing the membrane fusion protein and the encapsidation protein of avian infectious laryngotracheitis virus (rFP-LT) and avian encephalomyelitis virus, strain Calnek 1143 (AE) |
| Parental organism | Genetically modified folpox virus (FPV) |
| Transgene(s) | The membrane fusion protein and the encapsidation protein of avian infectious laryngotracheitis virus (rFP-LT) |
| Treated organism | Chickens |
| Indication(s) | Vaccination against fowlpox, avian infectious laryngotracheitis and avian encephalomyelitis |
| Administration route(s) | Subcutaneous wing web 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 | 18/03/2019, 25/10/2019 |
| EMA (CHMP) opinion (date) | Positive (21/02/2020) |
| European Commission authorisation number (date) | EU/2/20/250 (24/04/2020) |
| 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 |
| Innovax ND-ILT | |
|---|---|
| Application number | EMEA/V/C/005190 |
| Marketing authorisation holder | Intervet International B.V. |
| Name of the product | Innovax ND-ILT |
| Active substances | Cell-associated live recombinant turkey herpesvirus (strain HVT/NDV/ILT) expressing the fusion protein of newcastle disease virus and the glycoproteins gD and gI of infectious laryngotracheitis virus |
| Parental organism | Cell-associated live recombinant turkey herpesvirus |
| Transgene(s) | Fusion protein of Newcastle disease virus and the glycoproteins gD and gI of laryngotracheitis virus |
| Treated organism | Chickens, Embryonated chicken eggs |
| Indication(s) | Vaccination against Newcastle disease (ND) virus, avian infectious laryngotracheitis (ILT) virus and Marek’s disease (MD) virus |
| Administration route(s) | Subcutaneous injection, in ovo |
| 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 | 04/11/2019 |
| EMA (CHMP) opinion (date) | Positive (17/07/2020) |
| European Commission authorisation number (date) | EU/2/20/256 (16-09-2020) |
| 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 |
| Ultifend ND IBD | |
|---|---|
| Application number | EMEA/V/C/005347 |
| Marketing authorisation holder | CEVA-Phylaxia Veterinary Biologicals Co. Ltd |
| Name of the product | Ultifend ND IBD |
| Active substances | cell-associated live recombinant turkey herpesvirus expressing the fusion protein of ND virus and the VP2 protein of IBD virus |
| Parental organism | Turkey herpesvirus strain rHVT/ND/IBD |
| Transgene(s) | Fusion protein of Newcastle disease virus (NDV) and the VP2 protein of infectious bursal disease virus (IBDV) |
| Treated organism | Chickens, Embryonated chicken eggs |
| Indication(s) | Vaccination against Newcastle disease (ND) virus, avian infectious laryngotracheitis (ILT) virus and Marek’s disease (MD) virus |
| Administration route(s) | Subcutaneous 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 | 20/02/2020 |
| EMA (CHMP) opinion (date) | Positive (17/02/2021) |
| European Commission authorisation number (date) | EU/2/21/272 (20-04-2021) |
| 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 |
| Nobivac DP plus | |
|---|---|
| Application number | EMEA/V/C/005251 |
| Marketing authorisation holder | Intervet International B.V. |
| Name of the product | Nobivac DP plus |
| Active substances | Live attenuated canine distemper virus strain Onderstepoort and Live recombinant canine parvovirus strain 630a |
| Parental organism | CDV strain Onderstepoort and CPV strain 630a |
| Transgene(s) | Attenuated capsid of the circulating type 2c CPV isolate |
| Treated organism | Puppies |
| Indication(s) | Vaccination against canine distemper virus (CDV) and canine parvovirus (CPV) |
| Administration route(s) | Subcutaneous 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 | 20/02/2020, 25/06/2020, 23/09/2020 |
| EMA (CHMP) opinion (date) | Positive (09/10/2020) |
| European Commission authorisation number (date) | EU/2/20/265 (09-12-2020) |
| 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 |
| Newflend ND H9 | |
|---|---|
| Application number | EMEA/V/C/005860 |
| Marketing authorisation holder | CEVA-Phylaxia Co. Ltd |
| Name of the product | Newflend ND H9 |
| Active substances | Live recombinant turkey herpesvirus |
| Parental organism | Turkey herpesvirus |
| Transgene(s) | Fusion protein of Newcastle disease virus (NDV) and the hemagglutinin of low pathogenic avian influenza virus, subtype H9 (LPAI-H9) |
| Treated organism | Chickens |
| Indication(s) | Vaccination against LPAI |
| Administration route(s) | Subcutaneous injection or in ovo |
| 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 | 23/03/2022 |
| EMA (CHMP) opinion (date) | Positive (24/03/2023) |
| European Commission authorisation number (date) | EU/2/23/296 (15/05/2023) |
| 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 |
| Innovax-ILT-IBD | |
|---|---|
| Application number | EMEA/V/C/005905 |
| Marketing authorisation holder | Intervet International B.V |
| Name of the product | Innovax-ILT-IBD |
| Active substances | Live recombinant turkey herpesvirus |
| Parental organism | Turkey herpesvirus |
| Transgene(s) | VP2 gene of infectious bursal disease virus (IBDV) and the Infectious laryngotracheitis virus (ILTV) glycoproteins D and I |
| Treated organism | Chickens |
| Indication(s) | Vaccination against infectious Laryngotracheitis virus, infectious bursal disease and Marek's disease |
| Administration route(s) | Subcutaneous injection or intramuscular or in ovo |
| 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 | 12/04/2022 |
| EMA (CHMP) opinion (date) | Positive (15/02/2023) |
| European Commission authorisation number (date) | EU/2/23/292 (14/04/2023) |
| 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 |
| Poulvac Procerta HVT-IBD | |
|---|---|
| Application number | EMEA/V/C/006000 |
| Marketing authorisation holder | Zoetis Belgium SA |
| Name of the product | Poulvac Procerta HVT-IBD |
| Active substances | Live recombinant turkey herpesvirus |
| Parental organism | Turkey herpesvirus (HVT, FC-126 strain) |
| Transgene(s) | VP2 gene of infectious bursal disease virus (IBDV) |
| Treated organism | Chickens |
| Indication(s) | Vaccination infectious bursal disease and Marek's disease |
| Administration route(s) | Subcutaneous injection or in ovo |
| 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 | 10/11/2022 |
| EMA (CHMP) opinion (date) | Positive (08/09/2023) |
| European Commission authorisation number (date) | EU/2/23/300 (26/10/2023) |
| 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 |
| Prevexxion RN+HVT | |
|---|---|
| Application number | EMEA/V/C/006146 |
| Marketing authorisation holder | Boehringer Ingelheim Vetmedica GmbH |
| Name of the product | Prevexxion RN+HVT |
| Active substances | A genetically modified Marek’s disease virus serotype 1 strain RN1250 and the Turkey Herpesvirus FC126 vaccine strain |
| Parental organism | Attenuated Marek’s disease virus (MDV) CVI988 parental vaccine virus and turkey Herpesvirus (HVT) |
| Transgene(s) | RN1250 derived from CVI988 with 2 copies of REV LTR from MDV RMI strain |
| Treated organism | One-day-old chickens |
| Indication(s) | Vaccination against Marek's disease |
| Administration route(s) | Subcutaneous 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 | 16/01/2023 |
| EMA (CHMP) opinion (date) | Positive (08/09/2023) |
| European Commission authorisation number (date) | EU/2/23/302 (24/10/2023) |
| 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 |