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 |
|---|---|---|---|---|---|---|---|
| Crizotinib | XALKORI |
PFIZER | 2013 | 2011-08-26 | annual | 2017-08-25 | 2018-11-03 |
| COBIMETINIB | Cotellic |
ROCHE | 2017 | 2015-08-24 | 6 months | 2018-08-23 | 2018-11-01 |
| Agalsidase Alfa | Replagal |
Algorithm | 2017 | 2001-08-03 | 3 years | 2018-08-03 | 2018-11-01 |
| Epoetin Alfa | EPREX |
JANSSEN-CILAG | 1996 | 1988-04-04 | 3 years | 2018-08-03 | 2018-11-01 |
| Chloroquine | Resochin |
BAYER PHARMA AG | 1987 | 1965-09-01 | 3 years | 2018-08-01 | 2018-10-30 |
| Pioglitazone | ACTOS |
APM | 2002 | 2000-10-13 | 2 years | 2018-07-31 | 2018-10-29 |
| Glimepiride / pioglitazone hydrochloride, metformin / pioglitazone hydrochloride | DUETACT, ACTOSMET |
Jazeera Pharmaceutical Industries (JPI) | 2016 | 2000-10-13 | 2 years | 2018-07-31 | 2018-10-29 |
| Montelukast sodium | SINGULAIR |
MERCK SHARP & DOHME | 2016 | 1997-08-25 | 3 years | 2018-07-30 | 2018-10-28 |
| Montelukast | LEUKAS |
Jazeera Pharmaceutical Industries (JPI) | 2013 | 3 years | 2018-07-30 | 2018-10-28 | |
| Montelukast Sodium | ANTIKAST |
Pharma International Co | 2017 | 3 years | 2018-07-30 | 2018-10-28 |