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 |
|---|---|---|---|---|---|---|---|
| Blinatumomab | Blincyto | AMGEN | 6 months | ||||
| Aflibercept | Eylea | BAYER PHARMA AG | annual | ||||
| Bacillus clausii | Enterogermina | SANOFI PASTEUR | annual | ||||
| Rotavirus vaccine, live, oral, pentavalen | ROTATEQ | MERCK SHARP & DOHME | annual | ||||
| SAXAGLIPTIN, METFORMIN HYDROCHLORIDE | KOMBIGLYZE XR | AstraZeneca | annual | ||||
| Simeprevir | OLYSIO | JANSSEN-CILAG | Annual | ||||
| Hydroxyzine | ATARAX | GLAXOSMITHKLINE (GSK) | 18 months | ||||
| Darbepoetin Alfa | Aranesp | AMGEN | 3 years | ||||
| Ketotifen |
Gloditen 1mg tablets Gloditen 1mg/5ml |
SANOFI PASTEUR | 3 years | ||||
| Ketotifen (oral formulations) | TOTINAL | Hikma Pharmaceuticals PLC | 3 years |
