Post-Marketing Surveillance of REMSIMA 100mg (Infliximab) (monoclonal antibody, gene recombination) to Evaluate Its Safety and Efficacy in Korea (REMSIMA_PMS)

09/09/2015
23/04/2024
EU PAS number:
EUPAS10911
Study
Finalised
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Documents
Study protocol
Initial protocol

REMSIMA_PMS_v5.0_eng (2)

English (790.86 KB - PDF) View document
Study results
Study results

REMSIMA-PMS_Re-examination report_final_1

English (7.53 MB - PDF) View document
Study report
Study report

REMSIMA-PMS_Re-examination report_final_2

English (7.17 MB - PDF) View document

REMSIMA-PMS_Re-examination report_final_3

English (7.59 MB - PDF) View document

REMSIMA-PMS_Re-examination report_final_4

English (7.35 MB - PDF) View document
Other information
Study, other information

REMSIMA-PMS_Re-examination report_final_3.pdf

English (7.59 MB - PDF) View document

REMSIMA-PMS_Re-examination report_final_4.pdf

English (7.35 MB - PDF) View document