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Évaluation des risques générée par un processus de réglementation
(RA)
last updated: 16 juin 2026
Risk assessment of the Poulvac ST Vaccine - Technical Opinion No. 2741/2010.
EN
17 nov. 2020
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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 :Fort Dodge Saúde Animal ()Secteur privé (affaires et industrie)Rua Luis Fernando Rodriguez, 1701 Vila Boa VistaCampinas, São Paulo
13064798,Téléphone : +55 19 37456240,Télécopieur : +55 19 37456189,E-mail : elianaaguiar@cdn.com.br,Site Web : http://www.zoetis.com.br/index.br,
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Poulvac® ST vaccine| Fort Dodge Saúde Animal | Production de composés médicaux ou pharmaceutiques (humains ou animaux) (Vaccins)
- Commercial release 2741-2010.pdf [ Portugais ]
Food contamination by Salmonella is a serious public health problem worldwide. the bacteria
belongs to the Enterobacteriaceae family, and is widely distributed in nature, having as reservoirs
the intestinal tract of man and other animals.
belongs to the Enterobacteriaceae family, and is widely distributed in nature, having as reservoirs
the intestinal tract of man and other animals.
The risk of this vaccine is low, both for animals as well as the environment.
Studies observed in the literature with Salmonella Typhi mutant strains for the aroA gene did not show adverse reactions in human volunteers, which leads us to conclude that the vaccine strain for birds does not present significant risks for the human health.
It is not potentially causing significant degradation of the environment or harmful to human and animal health.
Tests to prove the safety of the product revealed that it is not harmful to public health, the environment or inoculated animals. The product is already approved and used in Australia and the USA and is registered for commercialization according to the copy included in the process. To date, no harmful effects from the use of the vaccine have been reported.
The company carried out a general monitoring program through pharmacovigilance, monitoring the product in the field and throughout its commercial life. It concludes that this activity is not potentially causing significant degradation of the environment or harmful to human and animal health.
It does not present adverse risks.
The Poulvac ST vaccine is not potentially causing significant environmental degradation or harmful to 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 | |
