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 |
|---|---|---|---|---|---|---|---|
| Ketoconazole | NIZORAL |
JANSSEN-CILAG | 1991 | 1980-06-01 | 3 years | 2018-05-31 | 2018-08-29 |
| Risperidone | RISPERDAL |
JANSSEN-CILAG | 1997 | 1992-12-01 | 3 years | 2018-05-31 | 2018-08-29 |
| Calcitonin (salmon) | Miacalcic Solution for injection |
NOVARTIS | 1984 | 1974-10-15 | 3 years | 2018-06-19 | 2018-08-28 |
| GLIBENCLAMIDE, METFORMIN | GLIMIFORT |
SANDOZ | 2015 | 2009-11-16 | 3 Years | 2018-06-18 | 2018-08-27 |
| Ceftriaxone | ROXCEF |
APM | 2000 | 3 years | 2018-05-26 | 2018-08-24 | |
| Co-trimoxazole | BALKATRIN |
APM | 1982 | 3 years | 2018-05-26 | 2018-08-24 | |
| CEFTRIAXONE | Rocephin |
ROCHE | 1985 | 2082-05-27 | 3 years | 2018-05-26 | 2018-08-24 |
| Ceftriaxone | SAMIXON |
Hikma Pharmaceuticals PLC | 1998 | 3 years | 2018-05-26 | 2018-08-24 | |
| Ceftriaxone | PROTEDEX |
GLAXOSMITHKLINE (GSK) | 2016 | 3 years | 2018-05-26 | 2018-08-24 | |
| Ceftriaxone | CEFAXON |
Jazeera Pharmaceutical Industries (JPI) | 2010 | 3 years | 2018-05-26 | 2018-08-24 |