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
Dulaglutide TRULICITY Eli Lilly 6 months
Rivaroxaban XARELTO BAYER PHARMA AG annual
Leflunomide RHEUFACT Jazeera Pharmaceutical Industries (JPI) annual
Naproxen NAPROX Hikma Pharmaceuticals PLC 3 years
Duloxetine Cymbalta Eli Lilly 3 years
Duloxetine DELAXIN Jazeera Pharmaceutical Industries (JPI) 3 years
Duloxetine Cymbalta Eli Lilly 3 years
Naproxen Aleve BAYER PHARMA AG 3 years
Fenofibrate LIPANTHYL ABBOTT Laboratories 3 years
Quetiapine QUETAL Jazeera Pharmaceutical Industries (JPI) 3 years


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