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 | ZANTAC | GLAXOSMITHKLINE (GSK) | 3 years | ||||
Ranitidine | RANIMAX | Jazeera Pharmaceutical Industries (JPI) | 3 years | ||||
Calcitonin (salmon) | Miacalcic Solution for injection | NOVARTIS | 3 years | ||||
GLIBENCLAMIDE, METFORMIN | GLIMIFORT | SANDOZ | 3 Years | ||||
Ceftriaxone | SAMIXON | Hikma Pharmaceuticals PLC | 3 years | ||||
CEFTRIAXONE | Rocephin | ROCHE | 3 years | ||||
Ceftriaxone | CEFAXON | Jazeera Pharmaceutical Industries (JPI) | 3 years | ||||
Ceftriaxone | PROTEDEX | GLAXOSMITHKLINE (GSK) | 3 years | ||||
Co-trimoxazole | BALKATRIN | APM | 3 years | ||||
Ceftriaxone | ROXCEF | APM | 3 years |