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 |
|---|---|---|---|---|---|---|---|
| Itraconazole | SPORANOX | JANSSEN-CILAG | 3 years | ||||
| Diphtheria, tetanus, pertussis, (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed) | Hexaxim | SANOFI PASTEUR | annual | ||||
| Human Anti-D Imunoglobulin | IgantiD | INSTITUTO GRIFOLS | 3 years | ||||
| Insulin Glulisine | Apidra | SANOFI PASTEUR | annual | ||||
| OXALIPLATIN | OXALIPLATIN | SANDOZ | 3 Years | ||||
| TOCILIZUMAB | Actemra | ROCHE | Annual | ||||
| Enoxaparin | Clexane | SANOFI PASTEUR | annual | ||||
| APRACLONIDINE | IOPIDINE 0.5% OPTH.SOLN. | ALCON | annual | ||||
| TROPICAMIDE | MYDRIACYL 1% EYE DROPS | ALCON | annual | ||||
| PROPARACAINE | ALCAIN DROPS 0.5% | ALCON | annual |
