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 |
|---|---|---|---|---|---|---|---|
| Pregabalin | GABEX |
JAMJOOM PHARMACEUTICALS COMPANY | 2013 | 2004-07-06 | annual | 2018-01-31 | 2018-04-30 |
| Haloperidol | HALDOL |
JANSSEN-CILAG | 1981 | 1960-04-25 | 3 years | 2018-01-24 | 2018-04-24 |
| Valproate Sodium | VALOPRA |
Jazeera Pharmaceutical Industries (JPI) | 2010 | 3 years | 2018-01-23 | 2018-04-23 | |
| SODIUM VALPROATE + VALPROIC ACID | Depakine Chrono |
SANOFI PASTEUR | 2000 | 1967-01-23 | 3 years | 2018-01-23 | 2018-04-22 |
| SODIUM VALPROATE | Depakine |
SANOFI PASTEUR | 2000 | 1967-01-23 | 3 years | 2018-01-23 | 2018-04-22 |
| Hydroflumethiazide, Spironolactone | ALDACTIDE |
PFIZER | 1987 | 1977-10-18 | 3 Years | 2018-01-01 | 2018-04-21 |
| ORLISTAT | Xenical |
ROCHE | 2000 | 2097-08-08 | 3 years | 2018-02-07 | 2018-04-18 |
| DIAZEPAM | Valium |
ROCHE | 1980 | 2062-02-08 | 3 years | 2018-02-07 | 2018-04-18 |
| Pomalidomide | Imnovid |
Algorithm | 2017 | 2013-02-08 | annual | 2018-02-07 | 2018-04-18 |
| Topiramate | TOPAMAX |
JANSSEN-CILAG | 1999 | 1995-07-18 | 3 years | 2018-01-18 | 2018-04-18 |