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 |
|---|---|---|---|---|---|---|---|
| Pregabalin | GABEX | JAMJOOM PHARMACEUTICALS COMPANY | annual | ||||
| Haloperidol | HALDOL | JANSSEN-CILAG | 3 years | ||||
| Valproate Sodium | VALOPRA | Jazeera Pharmaceutical Industries (JPI) | 3 years | ||||
| SODIUM VALPROATE | Depakine | SANOFI PASTEUR | 3 years | ||||
| SODIUM VALPROATE + VALPROIC ACID | Depakine Chrono | SANOFI PASTEUR | 3 years | ||||
| Hydroflumethiazide, Spironolactone | ALDACTIDE | PFIZER | 3 Years | ||||
| Topiramate | TOPAMAX | JANSSEN-CILAG | 3 years | ||||
| Pomalidomide | Imnovid | Algorithm | annual | ||||
| ORLISTAT | Xenical | ROCHE | 3 years | ||||
| DIAZEPAM | Valium | ROCHE | 3 years |
