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 |
|---|---|---|---|---|---|---|---|
| Vildagliptin | Galvus |
NOVARTIS | 2009 | 2007-02-14 | 3 years | 2018-02-28 | 2018-05-09 |
| Fingolimod hydrochloride | Gilenya |
NOVARTIS | 2011 | 2010-08-17 | annual | 2018-02-28 | 2018-05-09 |
| Voriconazole | VFEND |
PFIZER | 2006 | 2002-03-19 | annual | 2018-02-28 | 2018-05-09 |
| PIRFENIDONE | Esbriet |
ROCHE | 2016 | 2011-02-28 | Annual | 2018-02-27 | 2018-05-08 |
| BEVACIZUMAB | Avastin |
ROCHE | 2014 | 2004-02-26 | Annual | 2018-02-25 | 2018-05-06 |
| Pemetrexed | Alimta 500 mg |
Eli Lilly | 2007 | 2004-02-04 | 3 years | 2018-02-04 | 2018-05-05 |
| COBIMETINIB | Cotellic |
ROCHE | 2017 | 2015-08-24 | 6 months | 2018-02-23 | 2018-05-04 |
| Ruxolitinib | Jakavi |
NOVARTIS | 2014 | 2011-11-16 | annual | 2018-02-22 | 2018-05-03 |
| TRASTUZUMAB EMTANSINE | Kadcyla |
ROCHE | 2015 | 2013-02-22 | Annual | 2018-02-21 | 2018-05-02 |
| Atosiban | Tractocile |
FERRING | 2007 | 2000-01-20 | 3 years | 2018-01-31 | 2018-05-01 |