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 |
|---|---|---|---|---|---|---|---|
| Ranitidine | ZYDAC |
JAMJOOM PHARMACEUTICALS COMPANY | 1988 | 3 years | 2018-05-31 | 2018-08-30 | |
| Ranitidine | RANIMAX |
Jazeera Pharmaceutical Industries (JPI) | 2000 | 3 years | 2018-05-31 | 2018-08-29 | |
| Ranitidine | ZANTAC |
GLAXOSMITHKLINE (GSK) | 1984 | 3 years | 2018-05-31 | 2018-08-29 | |
| Ranitidine | ROLAN |
Hikma Pharmaceuticals PLC | 2003 | 3 years | 2018-05-31 | 2018-08-29 | |
| Ranitidine | Glotac |
SANOFI PASTEUR | 2013 | 1983-08-05 | 3 years | 2018-05-31 | 2018-08-29 |
| Imiglucerase | Cerezyme |
SANOFI PASTEUR | 2016 | 1994-05-23 | 3 years | 2018-05-31 | 2018-08-29 |
| Piroxicam | Piroxicam |
PFIZER | 1982 | 1979-04-03 | 3 Years | 2017-04-01 | 2018-08-29 |
| Ranitidine (HCl) | NADINE |
Pharma International Co | 2004 | 3 years | 2018-05-31 | 2018-08-29 | |
| Paracetamol | TYLENOL |
JANSSEN-CILAG | 2005 | 1955-06-03 | 3 years | 2018-05-31 | 2018-08-29 |
| Flunarizine Hydrochloride | SIBELIUM |
JANSSEN-CILAG | 2006 | 1977-06-01 | 3 years | 2018-05-31 | 2018-08-29 |