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 |
|---|---|---|---|---|---|---|---|
| Micafungin | MYCAMINE |
Jazeera Pharmaceutical Industries (JPI) | 2007 | 2008-04-25 | annual | 2017-10-08 | 2017-12-17 |
| Iloprost | Ventavis |
BAYER PHARMA AG | 2016 | 2003-09-16 | 3 years | 2017-09-15 | 2017-12-14 |
| Dapagliflozin | FORXIGA |
AstraZeneca | 2016 | 2012-10-05 | annual | 2017-10-04 | 2017-12-13 |
| Eltrombopag olamine | Eltrombopag Olamine |
GLAXOSMITHKLINE (GSK) | 2012 | 2010-03-11 | annual | 2017-09-30 | 2017-12-09 |
| Panitumumab | Vectibix |
AMGEN | 2013 | 2006-09-27 | Annual | 2017-09-30 | 2017-12-09 |
| Fluxetine | Prozac |
Eli Lilly | 2008 | 1986-09-07 | 3 years | 2017-08-07 | 2017-12-06 |
| Regorafenib | Stivarga |
BAYER PHARMA AG | 2014 | 2012-09-27 | annual | 2017-09-26 | 2017-12-05 |
| Suxamethonium | MIDARINE |
GLAXOSMITHKLINE (GSK) | 2004 | 3 years | 2017-08-31 | 2017-11-29 | |
| Estradiol hemihydrate | Vagifem 25 mcg |
NOVO NORDISK | 1998 | 2010-08-31 | 3 years | 2017-08-31 | 2017-11-29 |
| Estradiol hemihydrate | Vagifem 25 mcg |
NOVO NORDISK | 2017 | 2010-08-31 | 3 years | 2017-08-31 | 2017-11-29 |