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 |
|---|---|---|---|---|---|---|---|
| Typhoid vaccine | Typhim Vi |
SANOFI PASTEUR | 1998 | 1988-11-28 | 3 years | 2020-08-05 | 2020-11-03 |
| Diphtheria, tetanus, Pertussis & Hib | Tetract-Hib |
SANOFI PASTEUR | 1998 | 1993-08-03 | 3 years | 2020-08-02 | 2020-11-01 |
| QUETIAPINE FUMARATE | SICOPIN |
SANDOZ | 2016 | 2007-08-17 | 3 Years | 2020-07-31 | 2020-10-09 |
| Flumetasone pivalate | LOCACORTEN cream |
AMDIPHARMA | 2013 | 1964-01-01 | 3 years | 2020-06-30 | 2020-09-28 |
| Flumetasone pivalate /Clioquinol | LOCACORTEN-VIOFORM OINT |
AMDIPHARMA | 2013 | 1965-05-18 | 3 years | 2020-06-30 | 2020-09-28 |
| Flumetasone pivalate /salicylic acid | LOCASALEN OINT |
AMDIPHARMA | 2013 | 3 years | 2020-06-30 | 2020-09-28 | |
| Flumetasone pivalate | Locacorten |
AMDIPHARMA | 2013 | 1964-01-31 | 3 years | 2017-06-30 | 2020-09-28 |
| Flumetasone pivalate , salicylic acid | Locasalen |
AMDIPHARMA | 2013 | 1969-09-01 | 3 years | 2017-06-30 | 2020-09-28 |
| Flumetasone pivalate , Clioquinol | Locacorten Vioform |
AMDIPHARMA | 2013 | 1965-05-18 | 3 years | 2017-06-30 | 2020-09-28 |
| Epirubicin Hydrochloride | FARMARUBICIN |
PFIZER | 1988 | 1982-06-28 | 3 Years | 2017-06-30 | 2020-09-28 |