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 |
|---|---|---|---|---|---|---|---|
| Basiliximab | Simulect | NOVARTIS | 3 years | ||||
| OLOPATADINE | PATANOL 0.1% OPHTHALMIC SOLUTION | ALCON | 3 Years | ||||
| OLOPATADINE | PATADAY 0.2% OPHTHALMIC SOLUTION | ALCON | 3 Years | ||||
| Sunitinib Malate | SUTENT | PFIZER | annual | ||||
| Ceritinib | Zykadia | NOVARTIS | annual | ||||
| Acetaminophen | Perfalgan | BRISTOL-MYERS SQUIBB | annual | ||||
| VANDETANIB | Caprelsa | SANOFI PASTEUR | annual | ||||
| Insulin Glargine | Lantus | SANOFI PASTEUR | 6 months | ||||
| Metformin HCl | GLYMET | Pharma International Co | 3 years | ||||
| Metformin | GLUCARE | Jazeera Pharmaceutical Industries (JPI) | 3 years |
