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 |
|---|---|---|---|---|---|---|---|
| Prucalopride Succinate | RESOLOR |
JANSSEN-CILAG | 2017 | 2009-10-15 | 3 years | 2019-12-30 | 2020-03-29 |
| Abatacept | Orencia POWDER FOR SOLUTION FOR INFUSION |
BRISTOL-MYERS SQUIBB | 2010 | 2005-12-23 | 3 years | 2019-12-22 | 2020-03-22 |
| Abatacept | Orencia pre-filled syringe |
BRISTOL-MYERS SQUIBB | 2014 | 2005-12-23 | 3 years | 2019-12-22 | 2020-03-22 |
| Docetaxel | Taxotere |
SANOFI PASTEUR | 1991 | 1994-11-30 | 3 years | 2019-11-30 | 2020-02-28 |
| Docetaxel | Docetaxel |
PFIZER | 2013 | 2009-05-15 | 3 Years | 2019-11-30 | 2020-02-28 |
| Idarubicin Hydrochloride | ZAVEDOS |
PFIZER | 2013 | 1989-11-29 | 3 Years | 2019-11-30 | 2020-02-28 |
| Domperidone | DOMPY |
JAMJOOM PHARMACEUTICALS COMPANY | 2004 | 1978-03-01 | 3 years | 2019-11-19 | 2020-02-18 |
| Domperidone | MOTILIUM |
JANSSEN-CILAG | 1981 | 1978-03-01 | 3 years | 2019-11-19 | 2020-02-17 |
| Clopidogrel | Plavix |
SANOFI PASTEUR | 2001 | 1997-11-17 | 3 years | 2019-11-17 | 2020-02-15 |
| Isoflurane | FLORAN |
Hikma Pharmaceuticals PLC | 2003 | 1981-07-10 | 3 years | 2019-10-31 | 2020-01-29 |