Periodic safety reporting schedule
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 | 1981 | 1971-03-01 | 3 years | 2020-05-03 | 2020-08-01 |
| Insulin Lispro | Humalog Cart |
Eli Lilly | 2012 | 1995-04-30 | 3 years | 2020-04-30 | 2020-07-30 |
| Insulin Lispro | Humalog Kwik pen |
Eli Lilly | 2013 | 1995-04-30 | 3 years | 2020-04-30 | 2020-07-30 |
| Insulin Lispro | Humalog Mix 25 Cart |
Eli Lilly | 2001 | 1995-04-30 | 3 years | 2020-04-30 | 2020-07-30 |
| Insulin Lispro | Humalog Mix 25 Kwik pen |
Eli Lilly | 2011 | 1995-04-30 | 3 years | 2020-04-30 | 2020-07-30 |
| Insulin Lispro | Humalog Mix 50 Cart |
Eli Lilly | 2001 | 1995-04-30 | 3 years | 2020-04-30 | 2020-07-30 |
| Insulin Lispro | Humalog Mix 50 Kwik pen |
Eli Lilly | 2011 | 1995-04-30 | 3 years | 2020-04-30 | 2020-07-30 |
| Thyme Fluid Extract | Melrosum Syrup |
SANOFI PASTEUR | 1983 | 1976-07-20 | 3 years | 2020-04-29 | 2020-07-29 |
| Azithromycin | ZITHROMAX |
PFIZER | 1995 | 1991-04-04 | 3 Years | 2017-04-30 | 2020-07-29 |
| IRINOTECAN | IRINOTICAN EBEWE |
SANDOZ | 2015 | 2003-01-27 | 3 Years | 2020-05-04 | 2020-07-13 |