Periodic safety reporting schedule
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 |