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 |
|---|---|---|---|---|---|---|---|
| Testosterone undecanoate | Nebido |
BAYER PHARMA AG | 2007 | 2003-11-25 | 3 years | 2018-12-31 | 2019-03-31 |
| Botulinum Toxin 100 U | Botox 100 U |
Allergan | 1998 | 1989-12-29 | 3 Year | 2018-12-31 | 2019-03-30 |
| PRIMULA FLUID EXTRACT + THYME LIQUID EXTRACT | BRONCHICUM ELIXIR |
SANOFI PASTEUR | 2006 | 1962-03-09 | 3 years | 2018-12-31 | 2019-03-30 |
| Roxithromycin | Rulid |
SANOFI PASTEUR | 1991 | 1986-08-04 | 3 years | 2018-12-31 | 2019-03-30 |
| Thyme Liquid Extract + primula root Liquid extract | Bronchicum Elixir |
SANOFI PASTEUR | 2006 | 1962-03-09 | 3 years | 2018-12-31 | 2019-03-30 |
| Oxaliplatin | Oxaliplatin |
PFIZER | 2012 | 1997-01-14 | 3 Years | 2018-04-12 | 2019-03-28 |
| Entacapone | Comtan |
NOVARTIS | 2003 | 1998-09-16 | 3 years | 2019-01-16 | 2019-03-27 |
| Darunavir | PREZISTA |
JANSSEN-CILAG | 2015 | 2006-06-23 | 3 years | 2018-12-23 | 2019-03-23 |
| Valaciclovir | VALTREX |
GLAXOSMITHKLINE (GSK) | 1996 | 3 years | 2018-12-19 | 2019-03-19 | |
| cefotaxime | CEFTAX |
Hikma Pharmaceuticals PLC | 1993 | 3 years | 2018-12-18 | 2019-03-18 |