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 |
---|---|---|---|---|---|---|---|
CEFOTAXIME SODIUM | CLAFORAN | SANOFI PASTEUR | 3 years | ||||
Ceftizoxime | CEFIZOX | Hikma Pharmaceuticals PLC | 3 years | ||||
cefotaxime | CEFTAX | Hikma Pharmaceuticals PLC | 3 years | ||||
Caspofungin Acetate | CANCIDAS | MERCK SHARP & DOHME | 2 years | ||||
Ciclosporin | Sandimmun Concentrate for solution for infusion | NOVARTIS | 2 years | ||||
Ciclosporin | Sandimmun Neoral Capsule | NOVARTIS | 2 years | ||||
Verteporfin | Visudyne | NOVARTIS | 2 years | ||||
Ketamine HCl | TEKAM | Hikma Pharmaceuticals PLC | 3 years | ||||
Raloxefine | Evista | Eli Lilly | 3 years | ||||
PACLITAXEL | EBETAXEL | SANDOZ | 3 Years |