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 |
---|---|---|---|---|---|---|---|
ATEZOLIZUMAB | Tecentriq | ROCHE | 6 months | ||||
Bortezomib | VELCADE | JANSSEN-CILAG | 3 years | ||||
Fluticasone furoate | AVAMYS | GLAXOSMITHKLINE (GSK) | 3 years | ||||
Imatinib mesilate | Glivec | NOVARTIS | 3 years | ||||
Ofloxacin | OPTIFLOX | JAMJOOM PHARMACEUTICALS COMPANY | 3 years | ||||
ISOTRETINOIN | Roaccutane | ROCHE | Annual | ||||
Ofloxacin 0.3% | Oflox Eye Drops | Allergan | 3 Year | ||||
Ofloxacin | Tarivid | SANOFI PASTEUR | 3years | ||||
Tofacitinib Citrate | XELJANZ | PFIZER | 6 Months | ||||
FLUTICASONE PROPIONATE/FORMOTEROL FUMERATE |
FLUTIFORM | NAPP PHARMACEUTICALS LIMITED | annual |