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 |
|---|---|---|---|---|---|---|---|
| Azithromycin | azithromycin |
APM | 2003 | 1991-04-04 | 3 years | 2017-04-30 | 2017-07-29 |
| Azithromycin (systemic use ) | ZEROX |
Hikma Pharmaceuticals PLC | 2008 | 1991-04-04 | 3 years | 2017-04-30 | 2017-07-29 |
| Valsartan | DIOSTAR |
Pharma International Co | 2016 | 1996-05-13 | 3 years | 2017-04-30 | 2017-07-29 |
| Radium 223- Dichloride | Xofigo |
BAYER PHARMA AG | 2017 | 2013-05-15 | annual | 2017-05-14 | 2017-07-23 |
| Fluticasone furoate / vilanterol | RELVAR |
GLAXOSMITHKLINE (GSK) | 2015 | 2013-05-10 | annual | 2017-05-09 | 2017-07-18 |
| Isotretenoin | Isotretenoin |
GLAXOSMITHKLINE (GSK) | 2003 | 1982-05-07 | annual | 2017-05-04 | 2017-07-13 |
| Isotretinoin (oral formulations) | XERACTAN |
Jazeera Pharmaceutical Industries (JPI) | 2011 | 1982-05-07 | annual | 2017-05-04 | 2017-07-13 |
| Latanoprost / timolol | LATANOCOM |
JAMJOOM PHARMACEUTICALS COMPANY | 2003 | 1996-06-05 | 3 years | 2017-06-04 | 2017-07-05 |
| Simvastatin | SIMCOR |
Pharma International Co | 2008 | 1988-04-06 | 3 years | 2017-04-05 | 2017-07-04 |
| Simvastatin | SIMVA |
JAMJOOM PHARMACEUTICALS COMPANY | 1991 | 1988-04-06 | 3 years | 2017-04-05 | 2017-07-03 |