Periodic safety reporting schedule
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 |
|---|---|---|---|---|---|---|---|
| Ceftizoxime | CEFIZOX |
Hikma Pharmaceuticals PLC | 1990 | 3 years | 2018-12-18 | 2019-03-18 | |
| CEFOTAXIME SODIUM | CLAFORAN |
SANOFI PASTEUR | 1984 | 1979-12-18 | 3 years | 2018-12-18 | 2019-03-18 |
| Cefotaxime | TOTAM |
Jazeera Pharmaceutical Industries (JPI) | 2010 | 3 years | 2018-12-18 | 2019-03-18 | |
| Caspofungin Acetate | CANCIDAS |
MERCK SHARP & DOHME | 2003 | 2001-10-24 | 2 years | 2018-12-13 | 2019-03-13 |
| Ciclosporin | Sandimmun Concentrate for solution for infusion |
NOVARTIS | 1987 | 1982-12-28 | 2 years | 2018-12-31 | 2019-03-11 |
| Ciclosporin | Sandimmun Neoral Capsule |
NOVARTIS | 1997 | 1982-12-28 | 2 years | 2018-12-31 | 2019-03-11 |
| Verteporfin | Visudyne |
NOVARTIS | 2003 | 1999-12-15 | 2 years | 2018-12-31 | 2019-03-11 |
| Ketamine HCl | TEKAM |
Hikma Pharmaceuticals PLC | 1994 | 1968-10-12 | 3 years | 2018-12-09 | 2019-03-09 |
| Raloxefine | Evista |
Eli Lilly | 2008 | 1997-12-09 | 3 years | 2018-12-09 | 2019-03-09 |
| PACLITAXEL | EBETAXEL |
SANDOZ | 2006 | 1995-02-28 | 3 Years | 2018-12-28 | 2019-03-08 |