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psur
psur
Last Update: 2011-10-23
Usage Frequency: 5
Quality:
Warning: This alignment may be wrong.
Please delete it you feel so.
1996 psur
1996
Last Update: 2011-10-23
Usage Frequency: 1
Quality:
Warning: This alignment may be wrong.
Please delete it you feel so.
ips (psur):
psur:
Last Update: 2011-10-23
Usage Frequency: 2
Quality:
Warning: This alignment may be wrong.
Please delete it you feel so.
además, se debe presentar un psur actualizado:
in addition, an updated rmp should be submitted
Last Update: 2012-04-10
Usage Frequency: 5
Quality:
informe periódico actualizado de seguridad (psur):
periodic safety update reports (psur’ s):
Last Update: 2012-04-10
Usage Frequency: 3
Quality:
el titular de la autorización de comercialización presentará el psur anualmente.
the marketing authorisation holder will provide the psur annually.
Last Update: 2012-04-10
Usage Frequency: 3
Quality:
el titular de la autorización de comercialización deberá presentar el psur anual.
the marketing authorisation holder should submit annual psurs.
Last Update: 2017-04-26
Usage Frequency: 4
Quality:
el titular de la autorización de comercialización proveerá los psur en intervalos trianuales.
the marketing authorisation holder will provide the psur at 3-yearly intervals.
Last Update: 2017-04-26
Usage Frequency: 5
Quality:
el número de psur presentados se multiplicó por dos en 2000 comparado con respecto a 1999.
the number of psurs submitted doubled in 2000 compared to 1999.
Last Update: 2008-03-04
Usage Frequency: 1
Quality:
Warning: This alignment may be wrong.
Please delete it you feel so.
fecha de entrega: períodos establecidos en los calendarios estándar de remisión de psur.
due date:standard psur timings.
Last Update: 2008-03-04
Usage Frequency: 1
Quality:
Warning: This alignment may be wrong.
Please delete it you feel so.
por otra parte, francia consideraba que un informe psur de 5 años sobre la isotretinoína no era aceptable.
in addition, france considered that a psur reporting of 5 years for isotretinoin was not acceptable.
Last Update: 2012-04-10
Usage Frequency: 3
Quality:
el plan de presentación de los psur para oprymea comprimidos debe seguir el plan de presentación de los psur del medicamento de referencia.
the psur submission schedule for oprymea tablets should follow psurs submission schedule for the reference medicinal product.
Last Update: 2011-10-23
Usage Frequency: 1
Quality:
Warning: This alignment may be wrong.
Please delete it you feel so.
además, deberán seguir presentándose informes periódicos actualizados de seguridad (psur) anualmente.
furthermore, psurs should continue to be submitted on a yearly basis.
Last Update: 2012-04-10
Usage Frequency: 3
Quality:
el ciclo de psur de docetaxel winthrop seguirá el del producto al que hace referencia cruzada, taxotere, hasta que se especifique lo contrario.
the psur cycle of docetaxel winthrop is aligned with the cross-referred product, taxotere, until otherwise specified.
Last Update: 2012-04-10
Usage Frequency: 3
Quality:
a inmunogenicidad tras la reexposición a la idursulfasa dentro de los informes periódicos de actualización de seguridad (psur) anuales.
2.to submit data regarding immunogenicity after re-exposure to idursulfase within the annual psurs.
Last Update: 2008-03-04
Usage Frequency: 1
Quality:
Warning: This alignment may be wrong.
Please delete it you feel so.
además, el titular de la autorización de comercialización tendrá que presentar informes periódicos de seguridad (psur) anuales.
in addition, the periodic safety update reports (psur) are to be submitted on a yearly basis.
Last Update: 2012-04-10
Usage Frequency: 3
Quality:
presentación de los datos referentes a inmunogenicidad tras la reexposición a la idursulfasa dentro de los informes periódicos de actualización de seguridad (psur) anuales.
to submit data regarding immunogenicity after re-exposure to idursulfase within the annual psurs.
Last Update: 2011-10-23
Usage Frequency: 1
Quality:
Warning: This alignment may be wrong.
Please delete it you feel so.
