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
Ranitidine ZANTAC GLAXOSMITHKLINE (GSK) 3 years
Ranitidine RANIMAX Jazeera Pharmaceutical Industries (JPI) 3 years
Calcitonin (salmon) Miacalcic Solution for injection NOVARTIS 3 years
GLIBENCLAMIDE, METFORMIN GLIMIFORT SANDOZ 3 Years
Ceftriaxone SAMIXON Hikma Pharmaceuticals PLC 3 years
CEFTRIAXONE Rocephin ROCHE 3 years
Ceftriaxone CEFAXON Jazeera Pharmaceutical Industries (JPI) 3 years
Ceftriaxone PROTEDEX GLAXOSMITHKLINE (GSK) 3 years
Co-trimoxazole BALKATRIN APM 3 years
Ceftriaxone ROXCEF APM 3 years


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