Periodic safety reporting schedule

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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


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