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Risk Assessment generated by a regulatory process
(RA)
last updated: 16 Jun 2026
Risk assessment of the ProteqFlu Vaccine - Technical Opinion No. 3637/2013.
EN
16 May 2013
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Competent National Authority:National Technical Biosafety Commission ()Setor Policial Sul -SPO Área 5 Quadra 3 Bloco B - Térreo Salas 10 à 14Brasília, DF
CEP - 70610-200, BrazilPhone: (5561) 3411-5516,Fax: (5561) 3317-7475,Email: ctnbio@mct.gov.br,Website: http://www.ctnbio.gov.br,
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Organization:Merial Saúde Animal Ltda (Merial)Private sector (business and industry)Fazenda São Francisco s/nº - Caixa Postal: 242 - PAULINIA (SP)Paulínia, São Paulo
13140970, BrazilPhone: +55 19 3874-8601,Fax: +55 19 3874-8080,Email: luciana.soares@merial.com.br,Website: http://www.merial.com.br,
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Proteqflu - equine influenza vaccine| Merial | Production of medical or pharmaceutical compounds (human or animal) (Vaccines), Use as vaccine
- Commercial release 3637-2013.pdf [ Portuguese ]
The ProteqFlu vaccine for import, storage, transport and marketing activities. Its immunogenic agents are recombinant canarypox poxviruses, carrying the gene encoding the HA protein of the equine influenza virus, strains vCP1533 and vCP2241. The vaccine is produced by Merial in Lyon, France, and the product will be imported ready and finished. The ProteqFlu vaccine has been marketed in the European Union (approved by the European Medicines Agency) since 2003, with no relevant records of adverse events involving the GMOs in question.
The ProteqFlu vaccine, intended for active immunization of horses against equine influenza (H3N8) is not potentially causing adverse effects.
EN
EN
The risk classification of the genetically modified organism present in the vaccine is risk class 1 (low individual risk and low risk to the community), the data presented show that this vaccine does not imply additional risks to human health, the environment and the animal production, and the post-commercial release monitoring plan is comprehensive and well structured.
EN
It does not pose a risk to human, animal or environmental health.
The ProteqFlu vaccine, intended for active immunization of horses against equine influenza (H3N8) is not potentially causing significant environmental degradation or harmful to human and animal health.
Molecular traditional methods.
Yes
EN
| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
