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Risk Assessment generated by a regulatory process
(RA)
last updated: 09 Jul 2026
Risk assessment of the PROTEQFLU Vaccine - Technical Opinion No. 5486/2017.
EN
08 Jun 2017
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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 5486-2017.pdf [ Portuguese ]
ProteqFlu is a vaccine intended to protect domestic horses against equine influenza (H3N8).
There is no potential environmental hazard that can be identified by using the ProteqFlu vaccine.
Safety studies were conducted on non-target species involving canaries, ducks, chickens, pigs, rats and guinea pigs and the results support the product's safety profile.
There is no potential environmental hazard that can be identified by using the ProteqFlu vaccine.
It is not potentially causing significant environmental degradation or harmful to human health.
The analysis of the experimental data presented in the present request show that the GMOs in question are harmless to other species of animals, to man and to the environment.
The ProteqFlu vaccine is not potentially risk-causing.
The ProteqFlu vaccine, CTNBio concluded that the present request complies with the pertinent norms and legislation that aim to guarantee the biosafety of the environment, agriculture, human and animal health.
Molecular traditional methods.
Yes
No
No
EN
| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
