Post Marketing Surveillance To Observe Safety And Efficacy Of Enbrel In Pediatric Patients With Psoriasis
Status:
Withdrawn
Trial end date:
2013-09-01
Target enrollment:
Participant gender:
Summary
Enbrel was first approved as new medicine on 06 Oct 2003 in Korea and the indication of
Pediatric Psoriasis was approved on 23 Sep 2009. However, as required for any new indication
approved by Korea Food and Drug Administration (KFDA), safety and efficacy information of new
indication should be provided at minimum 600 subjects administered in the setting of routine
practice during the initial 4 years after new indication approved.