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 |
|---|---|---|---|---|---|---|---|
| LEVOFLOXACIN | LEVOFLOXACIN Sandoz |
SANDOZ | 2015 | 2005-03-17 | 3 Years | 2020-05-04 | 2020-07-13 |
| Valsartan/HCT | Co-Diovan Film-coated tablet 160/12.5 mg |
NOVARTIS | 2002 | 1997-09-25 | 3 years | 2020-04-30 | 2020-07-09 |
| Valsartan/HCT | Co-Diovan Film-coated tablet 160/25 mg |
NOVARTIS | 2003 | 1997-09-25 | 3 years | 2020-04-30 | 2020-07-09 |
| Valsartan/HCT | Co-Diovan Film-coated tablet 320/12.5 mg |
NOVARTIS | 2007 | 1997-09-25 | 3 years | 2020-04-30 | 2020-07-09 |
| Valsartan/HCT | Co-Diovan Film-coated tablet 320/25 mg |
NOVARTIS | 2008 | 1997-09-25 | 3 years | 2020-04-30 | 2020-07-09 |
| Valsartan/HCT | Co-Diovan Film-coated tablet 80/12.5 mg |
NOVARTIS | 2000 | 1997-09-25 | 3 years | 2020-04-30 | 2020-07-09 |
| Valsartan | Diovan |
NOVARTIS | 2002 | 1996-05-13 | 3 years | 2020-04-30 | 2020-07-09 |
| Paclitaxel | Paclitaxel |
PFIZER | 1998 | 1994-01-03 | 3 Years | 2018-12-28 | 2020-06-30 |
| Gatifloxacin 0.3% | Zymar Eye Drops |
Allergan | 2006 | 3 Years | 2020-03-31 | 2020-06-29 | |
| Gatifloxacin Sesquihydrate 0.5% | ZYMAXID eye drops solution |
Allergan | 2013 | 3 Years | 2020-03-31 | 2020-06-29 |