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 |
|---|---|---|---|---|---|---|---|
| SAXAGLIPTIN | ONGLYZA |
AstraZeneca | 2011 | 2009-07-31 | 3 years | 2017-07-30 | 2017-10-28 |
| Ibuprofen (indicated in ductus arteriosus) | BALKAPROFEN |
APM | 1982 | 2004-07-29 | 3 years | 2017-07-29 | 2017-10-27 |
| Ibuprofen (indicated in ductus arteriosus) | JAZOFEN |
Jazeera Pharmaceutical Industries (JPI) | 1999 | 2004-07-29 | 3 years | 2017-07-29 | 2017-10-27 |
| Ibuprofen | NUFEN |
Hikma Pharmaceuticals PLC | 1987 | 2004-07-29 | 3 years | 2017-07-29 | 2017-10-27 |
| Ribavirin | ribavirin |
APM | 2004 | 1999-05-07 | 3 years | 2017-07-24 | 2017-10-22 |
| Natalizumab | Tysabri |
Algorithm | 2014 | 2006-06-27 | annual | 2017-08-07 | 2017-10-16 |
| Idursulfase | Elaprase |
Algorithm | 2016 | 2007-01-08 | annual | 2017-07-23 | 2017-10-01 |
| Oxytocin | GYNOCIN |
Jazeera Pharmaceutical Industries (JPI) | 2016 | 1955-02-06 | 3 years | 2017-06-30 | 2017-09-28 |
| Aclidinium bromide | EKLIRA GENUAIR |
AstraZeneca | 2017 | 2012-07-20 | annual | 2017-07-20 | 2017-09-28 |
| METHOTREXATE | METHOTREXATE |
SANOFI PASTEUR | 1992 | 1962-01-01 | 3 years | 2020-06-30 | 2017-09-28 |