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 |
|---|---|---|---|---|---|---|---|
| BUSULPHAN | BUSULPHAN |
ASPEN | 1994 | 2003-07-09 | 3 years | 2019-07-08 | 2019-10-03 |
| Chlorthalidone | HYGROTON |
AMDIPHARMA | 2013 | 1959-06-24 | 3 years | 2019-06-30 | 2019-09-28 |
| Paliperidone | INVEGA |
JANSSEN-CILAG | 2009 | 2006-12-19 | 3 years | 2019-06-30 | 2019-09-28 |
| Belatacept | Nulojix |
BRISTOL-MYERS SQUIBB | 2015 | 2011-06-15 | 3 years | 2019-06-14 | 2019-09-12 |
| MITOXANTRONE HYDROCHLORIDE | MITOXANTRON EBEWE |
SANDOZ | 2006 | 2003-05-20 | 3 Years | 2019-06-30 | 2019-09-08 |
| Moxifloxacin | MAXIM |
JAMJOOM PHARMACEUTICALS COMPANY | 2001 | 1990-05-31 | 3 years | 2019-05-31 | 2019-08-30 |
| Tirofiban | Aggrastat |
Algorithm | 2011 | 2003-05-14 | 3 years | 2019-05-31 | 2019-08-29 |
| Loperamide | IMODIUx |
JANSSEN-CILAG | 2005 | 1973-05-31 | 3 years | 2019-05-31 | 2019-08-29 |
| Moxifloxacin | Avalox |
BAYER PHARMA AG | 2001 | 1999-06-21 | 3 years | 2019-05-31 | 2019-08-29 |
| Fusidic acid, Betamethasone | FUSIZONE |
BATTERJEE PHARMACETICAL FACTORY | 2010 | 1997-01-22 | 3 years | 2019-05-30 | 2019-08-28 |