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 |
|---|---|---|---|---|---|---|---|
| Meningococcal group a, c, w135, y conjugate vaccines (conjugated to tetanus toxoid carrier protein) | Menhibrix |
GLAXOSMITHKLINE (GSK) | 2012-04-20 | annual | 2017-04-19 | 2017-06-28 | |
| TELMISARTAN | MICARDIS |
BOEHRINGER INGELHEIM | 2000 | 1998-12-11 | annual | 2017-04-11 | 2017-06-20 |
| TELMISARTAN, HYDROCHLOROTHIAZIDE | MICARDIS PLUS |
BOEHRINGER INGELHEIM | 2005 | 1998-12-11 | annual | 2017-04-11 | 2017-06-20 |
| Meningococcal group a, c, w135, y conjugate vaccines (conjugated to corynebacterium diphtheriae crm197 protein) | meningococcal group a, c, w135, y conjugate vaccines (conjugated to Corynebacterium diphtheriae CRM197 protein) |
GLAXOSMITHKLINE (GSK) | 2011 | 2010-03-15 | 3 years | 2017-03-14 | 2017-06-12 |
| Tacrolimus (topical formulations) | VIOTOPIC |
Jazeera Pharmaceutical Industries (JPI) | 2007 | 2002-02-28 | annual | 2017-03-31 | 2017-06-09 |
| Tenofovir | VIREAD |
GLAXOSMITHKLINE (GSK) | 2013 | 2002-02-05 | annual | 2017-03-31 | 2017-06-09 |
| EXENATIDE | EXENATIDE |
AstraZeneca | 2011 | 2005-04-28 | annual | 2017-03-30 | 2017-06-08 |
| Amoxicillin | ULTRAMOX |
APM | 1989 | 1972-07-03 | 5 years | 2017-03-07 | 2017-06-05 |
| Dimethyl fumarate | Tecfidera |
Algorithm | 2016 | 2014-01-30 | annual | 2017-03-26 | 2017-06-04 |
| Mepolizumab | NUCALA |
GLAXOSMITHKLINE (GSK) | 2017 | 2015-12-02 | 6 months | 2017-03-23 | 2017-06-01 |