Periodic safety reporting schedule

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Active Substances Trade Name MAH Year of registration in Saudi Arabia International Birth Date (IBD) PSUR Submission Frequency Data Lock Point (DLP) Submission Date
Meningococcal group a, c, w135, y conjugate vaccines (conjugated to tetanus toxoid carrier protein) Menhibrix GLAXOSMITHKLINE (GSK) annual
TELMISARTAN, HYDROCHLOROTHIAZIDE MICARDIS PLUS BOEHRINGER INGELHEIM annual
TELMISARTAN MICARDIS BOEHRINGER INGELHEIM annual
Meningococcal group a, c, w135, y conjugate vaccines (conjugated to corynebacterium diphtheriae crm197 protein) meningococcal group a, c, w135, y conjugate vaccines (conjugated to Corynebacterium diphtheriae CRM197 protein) GLAXOSMITHKLINE (GSK) 3 years
Tenofovir VIREAD GLAXOSMITHKLINE (GSK) annual
Tacrolimus (topical formulations) VIOTOPIC Jazeera Pharmaceutical Industries (JPI) annual
EXENATIDE EXENATIDE AstraZeneca annual
Amoxicillin ULTRAMOX APM 5 years
Dimethyl fumarate Tecfidera Algorithm annual
Mepolizumab NUCALA GLAXOSMITHKLINE (GSK) 6 months


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