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 |
|---|---|---|---|---|---|---|---|
| Empagliflozin | Jardiance |
BOEHRINGER INGELHEIM | 2016 | 2014-04-17 | annual | 2018-04-17 | 2018-06-26 |
| Diphtheria, tetanus, pertussis, (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed) | Hexaxim |
SANOFI PASTEUR | 2015 | 2012-12-05 | annual | 2018-04-17 | 2018-06-26 |
| Human Anti-D Imunoglobulin | IgantiD |
INSTITUTO GRIFOLS | 2017 | 1996-04-01 | 3 years | 2018-03-28 | 2018-06-26 |
| Insulin Glulisine | Apidra |
SANOFI PASTEUR | 2008 | 2004-04-16 | annual | 2018-04-16 | 2018-06-25 |
| OXALIPLATIN | OXALIPLATIN |
SANDOZ | 2008 | 2002-10-14 | 3 Years | 2018-04-12 | 2018-06-21 |
| TOCILIZUMAB | Actemra |
ROCHE | 2014 | 2005-04-11 | Annual | 2018-04-10 | 2018-06-19 |
| Enoxaparin | Clexane |
SANOFI PASTEUR | 2002 | 1987-04-03 | annual | 2018-04-03 | 2018-06-12 |
| TROPICAMIDE | MYDRIACYL 1% EYE DROPS |
ALCON | 2000 | 1951-12-31 | annual | 2018-03-31 | 2018-06-10 |
| PROPARACAINE | ALCAIN DROPS 0.5% |
ALCON | 1981 | 1971-12-22 | annual | 2018-03-31 | 2018-06-10 |
| APRACLONIDINE | IOPIDINE 0.5% OPTH.SOLN. |
ALCON | 1997 | 1987-12-31 | annual | 2018-03-31 | 2018-06-10 |