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 |
|---|---|---|---|---|---|---|---|
| METHOTREXATE | METHOTREXATE |
SANOFI PASTEUR | 1992 | 1962-01-01 | 3 years | 2020-06-30 | 2017-09-28 |
| Epirubicin | EPIRUBICIN JAZEERA |
Jazeera Pharmaceutical Industries (JPI) | 2014 | 1982-06-28 | 3 years | 2017-06-30 | 2017-09-28 |
| Cilastatin / imipenem | ZAYNAM |
Jazeera Pharmaceutical Industries (JPI) | 2016 | 1984-06-28 | 3 years | 2017-06-27 | 2017-09-25 |
| Pitavastatin | Livazo |
Algorithm | 2014 | 2003-07-17 | annual | 2017-07-16 | 2017-09-24 |
| Aripiprazole | ARIPO |
Jazeera Pharmaceutical Industries (JPI) | 2016 | 2004-06-04 | annual | 2017-07-16 | 2017-09-24 |
| Rotavirus vaccine monovalent (live, oral) | ROTARIX |
GLAXOSMITHKLINE (GSK) | 2013 | 2006-02-21 | annual | 2017-07-11 | 2017-09-19 |
| Cyproterone acetate-Ethinylestradiol | Diane-35 |
BAYER PHARMA AG | 1989 | 1972-10-13 | 3 years | 2017-05-31 | 2017-08-29 |
| Tedizolid phosphate | Sivextro |
BAYER PHARMA AG | 2016 | 2014-06-20 | 1 year | 2017-06-20 | 2017-08-29 |
| Tramadol | TRAMADONE |
APM | 2002 | 3 years | 2017-05-22 | 2017-08-20 | |
| Human fibrinogen / human thrombin | TACHOSIL |
Jazeera Pharmaceutical Industries (JPI) | 2009 | 2004-06-08 | 6 months | 2017-06-08 | 2017-08-17 |