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 |
|---|---|---|---|---|---|---|---|
| Azithromycin | azithromycin | APM | 3 years | ||||
| Valsartan | DIOSTAR | Pharma International Co | 3 years | ||||
| Radium 223- Dichloride | Xofigo | BAYER PHARMA AG | annual | ||||
| Fluticasone furoate / vilanterol | RELVAR | GLAXOSMITHKLINE (GSK) | annual | ||||
| Isotretenoin | Isotretenoin | GLAXOSMITHKLINE (GSK) | annual | ||||
| Isotretinoin (oral formulations) | XERACTAN | Jazeera Pharmaceutical Industries (JPI) | annual | ||||
| Latanoprost / timolol | LATANOCOM | JAMJOOM PHARMACEUTICALS COMPANY | 3 years | ||||
| Simvastatin | SIMCOR | Pharma International Co | 3 years | ||||
| Simvastatin | SIMVA | JAMJOOM PHARMACEUTICALS COMPANY | 3 years | ||||
| Febuxostat | Adenuric | Algorithm | annual |
