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 |
|---|---|---|---|---|---|---|---|
| Imiquimod | ALDARA 5% CREAM |
MEDA PHARMA GmbH & Co KG | 2011 | 1998-09-18 | 3 years | 2017-01-26 | 2017-04-26 |
| Pregabalin | PREX |
Jazeera Pharmaceutical Industries (JPI) | 2012 | 2004-07-06 | annual | 2017-01-31 | 2017-04-11 |
| Sildenafil | FALLAH |
Jazeera Pharmaceutical Industries (JPI) | 2014 | 1998-09-14 | 3 years | 2016-12-31 | 2017-03-31 |
| Abacavir | ZIAGEN |
GLAXOSMITHKLINE (GSK) | 2003 | 1998-06-29 | 3 years | 2016-12-31 | 2017-03-31 |
| Abacavir / lamivudine | KIVEXA |
GLAXOSMITHKLINE (GSK) | 2015 | 2003-11-14 | 3 years | 2016-12-31 | 2017-03-31 |
| Abacavir / lamivudine / zidovudine | TRIZIVIR |
GLAXOSMITHKLINE (GSK) | 2003 | 2000-12-28 | 3 years | 2016-12-31 | 2017-03-31 |
| Sorafenib | Nexavar |
BAYER PHARMA AG | 2009 | 2005-12-20 | 3 years | 2016-12-31 | 2017-03-31 |
| Sildenafil | ERECTA |
JAMJOOM PHARMACEUTICALS COMPANY | 2013 | 1998-09-14 | 3 years | 2016-12-31 | 2017-03-30 |
| Dolutegravir / abacavir / lamivudine | TRIUMEQ |
GLAXOSMITHKLINE (GSK) | 2017 | 2014-01-16 | 6 months | 2016-07-16 | 2017-03-27 |
| Dolutegravir | TIVICAY |
GLAXOSMITHKLINE (GSK) | 2014 | 2014-01-16 | 6 months | 2016-07-16 | 2017-03-27 |