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 |
|---|---|---|---|---|---|---|---|
| APRACLONIDINE | IOPIDINE 0.5% OPTH.SOLN. |
ALCON | 1997 | 1987-12-31 | annual | 2018-03-31 | 2018-06-10 |
| Cabergoline | DOSTINEX |
PFIZER | 2000 | 1992-03-13 | 3 Years | 2018-03-12 | 2018-06-10 |
| Sildenafil Citrate | VIAGRA |
PFIZER | 2010 | 1998-02-05 | 3 Years | 2021-12-31 | 2018-06-06 |
| Canagliflozin | INVOKANA |
JANSSEN-CILAG | 2016 | 2013-03-29 | Annual | 2018-03-28 | 2018-06-06 |
| OCRELIZUMAB | Ocrevus |
ROCHE | 2018 | 6 months | 2018-03-27 | 2018-06-05 | |
| Bimatoprost | Lumigan Eye Drops |
Allergan | 2004 | 2002-03-08 | 3 Years | 2018-03-07 | 2018-06-05 |
| Meningococcal group a, c, w135, y polysaccharide vaccine | Menveo |
GLAXOSMITHKLINE (GSK) | 2011 | 2007-03-05 | 3 years | 2018-03-04 | 2018-06-02 |
| Ipilimumab | Yervoy |
BRISTOL-MYERS SQUIBB | 2015 | 2011-03-25 | annual | 2018-03-24 | 2018-06-02 |
| hydroxyethyl starch 6% (HES 130/0.4) in normal saline solution | Voluven 6% IV infusion |
FRESENIUS KABI | 2007 | 1999-06-22 | Annual | 2018-03-01 | 2018-06-01 |
| Dobutamine Hydrochloride | Dobutamine Hydrochloride |
PFIZER | 1998 | 1993-06-24 | 3 Years | 2018-03-01 | 2018-05-30 |