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 |
|---|---|---|---|---|---|---|---|
| OLOPATADINE | PATANOL 0.1% OPHTHALMIC SOLUTION |
ALCON | 2003 | 1996-12-01 | 3 Years | 2018-04-30 | 2018-07-09 |
| Basiliximab | Simulect |
NOVARTIS | 2001 | 1998-04-17 | 3 years | 2018-04-30 | 2018-07-09 |
| OBINUTUZUMAB | Gazyva |
ROCHE | 2016 | 2013-11-01 | 6 months | 2018-04-30 | 2018-07-09 |
| Sunitinib Malate | SUTENT |
PFIZER | 2010 | 2006-01-26 | annual | 2017-04-30 | 2018-07-09 |
| Ceritinib | Zykadia |
NOVARTIS | 2016 | 2014-04-29 | annual | 2018-04-28 | 2018-07-07 |
| Acetaminophen | Perfalgan |
BRISTOL-MYERS SQUIBB | 2004 | 2001-06-19 | annual | 2018-05-07 | 2018-07-05 |
| VANDETANIB | Caprelsa |
SANOFI PASTEUR | 2016 | 2011-04-06 | annual | 2018-04-06 | 2018-07-05 |
| Metformin | GLUCARE |
Jazeera Pharmaceutical Industries (JPI) | 2002 | 3 years | 2018-04-01 | 2018-06-30 | |
| Insulin Glargine | Lantus |
SANOFI PASTEUR | 2007 | 2000-04-21 | 6 months | 2018-04-21 | 2018-06-30 |
| Metformin HCl | GLYMET |
Pharma International Co | 2006 | 3 years | 2018-04-01 | 2018-06-30 |