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 |
|---|---|---|---|---|---|---|---|
| Bendamustin Hydrochloride | RIBOMUSTIN |
ASTELLAS PHARMA | 2016 | 1971-11-10 | annual | 2018-01-06 | 2018-03-17 |
| ALECTINIB | Alecensa |
ROCHE | 2017 | 2014-07-04 | 6 months | 2018-01-03 | 2018-03-14 |
| Tobramycin | Tobi Podhaler |
NOVARTIS | 2013 | 2010-11-25 | 2 years | 2017-12-31 | 2018-03-11 |
| Omalizumab | Xolair |
NOVARTIS | 2006 | 2002-06-13 | annual | 2017-12-31 | 2018-03-11 |
| PHYTOMENADION | Konakion |
ROCHE | 1980 | 3 years | 2017-12-31 | 2018-03-11 | |
| ALLOPURINOL | ZYLORIC |
ASPEN | 2003 | 1966-01-01 | 3 years | 2018-12-31 | 2018-03-11 |
| PHENYLEPHRINE HYDROCHLORIDE | MYDFRIN 2.5% DROPS |
ALCON | 1982 | 1956-09-01 | annual | 2018-01-01 | 2018-03-10 |
| TICAGRELOR | BRILINTA |
AstraZeneca | 2013 | 2010-12-31 | 1 year | 2017-12-30 | 2018-03-10 |
| Lenalidomide | Revlimid |
Algorithm | 2016 | 2007-06-14 | annual | 2017-12-26 | 2018-03-06 |
| Secukinumab | Cosentyx |
NOVARTIS | 2016 | 2014-12-26 | annual | 2017-12-25 | 2018-03-05 |