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 |
|---|---|---|---|---|---|---|---|
| Imiquimod | ALDARA 5% CREAM | MEDA PHARMA GmbH & Co KG | 3 years | ||||
| Pregabalin | PREX | Jazeera Pharmaceutical Industries (JPI) | annual | ||||
| Sildenafil | FALLAH | Jazeera Pharmaceutical Industries (JPI) | 3 years | ||||
| Sorafenib | Nexavar | BAYER PHARMA AG | 3 years | ||||
| Abacavir / lamivudine / zidovudine | TRIZIVIR | GLAXOSMITHKLINE (GSK) | 3 years | ||||
| Abacavir / lamivudine | KIVEXA | GLAXOSMITHKLINE (GSK) | 3 years | ||||
| Abacavir | ZIAGEN | GLAXOSMITHKLINE (GSK) | 3 years | ||||
| Sildenafil | ERECTA | JAMJOOM PHARMACEUTICALS COMPANY | 3 years | ||||
| Dolutegravir / abacavir / lamivudine | TRIUMEQ | GLAXOSMITHKLINE (GSK) | 6 months | ||||
| Dolutegravir | TIVICAY | GLAXOSMITHKLINE (GSK) | 6 months |
