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 |
|---|---|---|---|---|---|---|---|
| Rifampicin/Isoniazid | Rifinah | SANOFI PASTEUR | 3 years | ||||
| Bemiparin | HIBOR | Hikma Pharmaceuticals PLC | 3 years | ||||
| Ethinylestradiol-Levonorgestrel | Logynon | BAYER PHARMA AG | 3 years | ||||
| Retapamulin | ALTARGO | GLAXOSMITHKLINE (GSK) | 3 years | ||||
| RIFAMPICIN | RIMACTAZID 300MG TAB. | SANDOZ | 3 Years | ||||
| BRINZOLAMIDE, TIMOLOL MALEATE | AZARGA EYE DROPS | ALCON | 3 Years | ||||
| Golimumab | SIMPONI | JANSSEN-CILAG | 3 years | ||||
| PRAMIPEXOLE | Sifrol | BOEHRINGER INGELHEIM | 3 years | ||||
| Tacrolimus monohydrate | PROTOPIC 0.03% OINTMENT | ASTELLAS PHARMA | 3 years | ||||
| Olanzapine | PRANZA | Jazeera Pharmaceutical Industries (JPI) | 3 years |
