Periodic Safety Update Reports Submission Schedule
Periodic Safety Update Reports Submission 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 |
|---|---|---|---|---|---|---|---|
| RURIOCTOCOG ALFA PEGOL | ADYNOVATE | Takeda | 2020 | 2018-11-13 | Annual | 2023-11-12 | 2025-07-07 |
| PRUCALOPRIDE SUCCINATE | RESOLOR | Takeda | 2016 | 2009-10-15 | Other | 2023-10-14 | 2024-01-09 |
| ACALABRUTINIB | CALQUENCE | AstraZeneca | 2020 | 2017-10-31 | Annual | 2023-10-30 | 2024-01-08 |
| NIMODIPINE | NIMOTOP | Bayer | 1996 | 1987-11-01 | 5 Years | 2023-11-01 | 2024-01-07 |
| ELVITEGRAVIR/COBICISTAT/EMTRICITABINE/TENOFOVIR ALAFENAMIDE | GENVOYA | Gilead Sciences | 2017 | 2012-08-27 | Annual | 2023-11-04 | 2024-01-04 |
| SOMATROGON | NGENLA | Pfizer | 2023 | 2021-10-26 | 6 Months | 2025-07-07 | 2024-01-04 |
| DICLOFENAC DIETHYLAMINE, DICLOFENAC SODIUM, DICLOFENAC FREE ACID) | DICLOFENAC TOPICAL PRODUCTS | Haleon | 1991 | 1977-05-11 | 5 Years` | 2023-09-30 | 2024-01-02 |
| POSACONAZOLE | NOXAFIL | MSD | 2021 | 2005-09-25 | Annual | 2023-09-25 | 2024-01-01 |