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 |
|---|---|---|---|---|---|---|---|
| Diphtheria, Tetanus & Pertussis vaccine | DT Coq | SANOFI PASTEUR | 3 years | ||||
| AMIODARONE | SEDACORON | SANDOZ | 3 Years | ||||
| Methylprednisolone aceponate | Advantan | BAYER PHARMA AG | 3 years | ||||
| Methylprednisolone | MEDROLONE | Jazeera Pharmaceutical Industries (JPI) | 3 years | ||||
| 5-FLUOROURACIL | FLUOROURACIL EBEWE AMP | SANDOZ | 3 Years | ||||
| Norelgestromin /Ethinyl Estradiol | EVRA | JANSSEN-CILAG | 3 years | ||||
| FONDAPARINUX | ARIXTRA | ASPEN | annual | ||||
| Venetoclax | VENCLEXTA | ABBVIE | 6 months | ||||
|
Diphtheria, Tetanus Toxoids, Acellular Pertussis, Inactivated Poliomyelitis & Haemophilus b Conjugate Vaccine |
Pediacel | SANOFI PASTEUR | 3 years | ||||
| Ibrutinib | IMBRUVICA | JANSSEN-CILAG | Annual |
