TERMIUM Plus®
The Government of Canada’s terminology and linguistic data bank.
DOSSIER VARIANTES [1 record]
Record 1 - internal organization data 2006-11-28
Record 1, English
Record 1, Subject field(s)
- Epidemiology
- Immunology
Record 1, Main entry term, English
- variation dossier
1, record 1, English, variation%20dossier
correct
Record 1, Abbreviations, English
Record 1, Synonyms, English
Record 1, Textual support, English
Record number: 1, Textual support number: 1 CONT
The task of the ETF (EMEA [European Medicines Agency] Task Force) will include: ... interactions with the manufacturers, including ongoing scientific discussions prior to the submission of the pandemic variation dossier. 2, record 1, English, - variation%20dossier
Record number: 1, Textual support number: 1 OBS
Pandemic variation includes only quality data related to the pandemic influenza strain, commitment to gather clinical information during the pandemic and fast track approval. 3, record 1, English, - variation%20dossier
Record 1, French
Record 1, Domaine(s)
- Épidémiologie
- Immunologie
Record 1, Main entry term, French
- dossier de variantes
1, record 1, French, dossier%20de%20variantes
masculine noun
Record 1, Abbreviations, French
Record 1, Synonyms, French
Record 1, Textual support, French
Record number: 1, Textual support number: 1 CONT
En avril 2004, le groupe d'experts des vaccins (VEG) de l'EMEA [European Medicines Agency] a proposé aux industriels une nouvelle procédure, en deux temps. Elle prévoit d'abord la soumission d'un «dossier pandémique de base» (core pandemic dossier), relatif à une sorte de «vaccin prototype» que peuvent enregistrer les industriels à n'importe quel moment. Ensuite, dès l'annonce par l'OMS [Organisation mondiale de la santé] de la composition antigénique de la souche pandémique, un dossier de variantes (variation dossier), relatif à la vraie souche épidémique, pourrait être approuvé en quarante-huit heures. 1, record 1, French, - dossier%20de%20variantes
Record 1, Spanish
Record 1, Campo(s) temático(s)
- Epidemiología
- Inmunología
Record 1, Main entry term, Spanish
- solicitud de modificación
1, record 1, Spanish, solicitud%20de%20modificaci%C3%B3n
correct, feminine noun
Record 1, Abbreviations, Spanish
Record 1, Synonyms, Spanish
- solicitud de modificación pandémica 1, record 1, Spanish, solicitud%20de%20modificaci%C3%B3n%20pand%C3%A9mica
correct, feminine noun
Record 1, Textual support, Spanish
Record number: 1, Textual support number: 1 CONT
Esta vacuna "tamaño natural" no se comercializaría hasta que no se produjera una situación de pandemia en la Comunidad y no se hubiera depositado una solicitud de modificación que contuviera toda la información relevante sobre la cepa pandémica de que se tratara. Al producirse la situación de pandemia se presentaría la solicitud de modificación pandémica. La modificación contendría únicamente datos nuevos y pertinentes con respecto a la cepa pandémica, y su evaluación y autorización se efectuarían por la "vía rápida". 1, record 1, Spanish, - solicitud%20de%20modificaci%C3%B3n
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