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 |
|---|---|---|---|---|---|---|---|
| Crizotinib | XALKORI | PFIZER | annual | ||||
| COBIMETINIB | Cotellic | ROCHE | 6 months | ||||
| Agalsidase Alfa | Replagal | Algorithm | 3 years | ||||
| Epoetin Alfa | EPREX | JANSSEN-CILAG | 3 years | ||||
| Chloroquine | Resochin | BAYER PHARMA AG | 3 years | ||||
| Pioglitazone | ACTOS | APM | 2 years | ||||
| Glimepiride / pioglitazone hydrochloride, metformin / pioglitazone hydrochloride | DUETACT, ACTOSMET | Jazeera Pharmaceutical Industries (JPI) | 2 years | ||||
| Montelukast | LEUKAS | Jazeera Pharmaceutical Industries (JPI) | 3 years | ||||
| Montelukast Sodium | ANTIKAST | Pharma International Co | 3 years | ||||
| Montelukast sodium | SINGULAIR | MERCK SHARP & DOHME | 3 years |
