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 |
---|---|---|---|---|---|---|---|
Mebendazole | VERMOX | JANSSEN-CILAG | 3 years | ||||
Insulin Lispro | Humalog Mix 25 Kwik pen | Eli Lilly | 3 years | ||||
Insulin Lispro | Humalog Mix 25 Cart | Eli Lilly | 3 years | ||||
Insulin Lispro | Humalog Kwik pen | Eli Lilly | 3 years | ||||
Insulin Lispro | Humalog Cart | Eli Lilly | 3 years | ||||
Insulin Lispro | Humalog Mix 50 Kwik pen | Eli Lilly | 3 years | ||||
Insulin Lispro | Humalog Mix 50 Cart | Eli Lilly | 3 years | ||||
Azithromycin | ZITHROMAX | PFIZER | 3 Years | ||||
Thyme Fluid Extract | Melrosum Syrup | SANOFI PASTEUR | 3 years | ||||
IRINOTECAN | IRINOTICAN EBEWE | SANDOZ | 3 Years |