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 |
|---|---|---|---|---|---|---|---|
| Methotrexate | Methotrexate |
PFIZER | 1998 | 1953-12-07 | 3 Years | 2017-06-30 | 2022-09-28 |
| 9-2- | XALACOM |
PFIZER | 2003 | 2000-12-15 | 3 Years | 2017-06-04 | 2022-09-02 |
| CANDESARTAN CILEXETIL | DICERAN |
SANDOZ | 2016 | 2 Years | 2022-04-28 | 2022-07-07 | |
| Rabeprazole Sodium | PARIET |
JANSSEN-CILAG | 2007 | 1997-10-13 | 3 years | 2021-10-13 | 2022-01-11 |
| Sufentanil Citrate | SUFENTA |
JANSSEN-CILAG | 1997 | 1978-11-30 | 3 years | 2020-11-30 | 2021-02-28 |
| DESFLURANE | SUPRANE INHALATION ANAESTHITIC - 240mL |
Baxter | 2002 | 1992-09-18 | 3 years | 2020-09-30 | 2020-12-29 |
| Vigabatrin | Sabril |
SANOFI PASTEUR | 1994 | 1989-09-22 | 3 years | 2020-09-22 | 2020-12-21 |
| Leflunomide | Arava |
SANOFI PASTEUR | 2009 | 1998-09-10 | 3 years | 2020-09-10 | 2020-12-19 |
| Sirolimus | RAPAMUNE |
PFIZER | 2011 | 1999-09-15 | 3 Years | 2017-09-14 | 2020-12-13 |
| Diphtheria, Tetanus Toxoids, Acellular Pertussis & Haemophilus b Conjugate Vaccine |
Actacel |
SANOFI PASTEUR | 2005 | 1998-08-31 | 3 years | 2020-08-30 | 2020-11-29 |