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Évaluation des risques générée par un processus de réglementation
(RA)
last updated: 09 juil. 2026
Risk assessment of the PROTEQFLU Vaccine - Technical Opinion No. 5486/2017.
EN
08 juin 2017
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Autorité nationale compétente :National Technical Biosafety Commission ()Setor Policial Sul -SPO Área 5 Quadra 3 Bloco B - Térreo Salas 10 à 14Brasília, DF
CEP - 70610-200,Téléphone : (5561) 3411-5516,Télécopieur : (5561) 3317-7475,E-mail : ctnbio@mct.gov.br,Site Web : http://www.ctnbio.gov.br,
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Organisation :Merial Saúde Animal Ltda (Merial)Secteur privé (affaires et industrie)Fazenda São Francisco s/nº - Caixa Postal: 242 - PAULINIA (SP)Paulínia, São Paulo
13140970,Téléphone : +55 19 3874-8601,Télécopieur : +55 19 3874-8080,E-mail : luciana.soares@merial.com.br,Site Web : http://www.merial.com.br,
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Proteqflu - equine influenza vaccine| Merial | Production de composés médicaux ou pharmaceutiques (humains ou animaux) (Vaccins), Use as vaccine
- Commercial release 5486-2017.pdf [ Portugais ]
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.
Oui
Non
Non
FR
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| Décision de pays ou tout autre communication | Évaluation des risques | 1 | |
