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 |
|---|---|---|---|---|---|---|---|
| FILGRASTIM | ZARZIO |
SANDOZ | 2015 | 2009-02-06 | 3 Years | 2019-01-31 | 2019-04-11 |
| LEVOTHYROXINE (THYROXINE) SODIUM | L- THYROX HEXAL |
SANDOZ | 2009 | 1985-03-05 | 3 Years | 2019-01-31 | 2019-04-11 |
| Rivastigmine | Exelon Capsule |
NOVARTIS | 2000 | 1997-07-31 | 3 years | 2019-01-31 | 2019-04-11 |
| Rivastigmine | Exelon Transdermal patch |
NOVARTIS | 2010 | 1997-07-31 | 3 years | 2019-01-31 | 2019-04-11 |
| CARBOPLATIN | CARBOPLATIN "EBEWE" |
SANDOZ | 2001 | 1997-10-12 | 3 Years | 2019-01-23 | 2019-04-03 |
| TESTOSTERONE UNDECANOATE | ANDRIOL TESTOCAPS |
MERCK SHARP & DOHME | 1986 | 1978-01-07 | 3 years | 2018-12-31 | 2019-03-31 |
| TESTOSTERONE | SUSTANON |
MERCK SHARP & DOHME | 1983 | 1978-01-07 | 3 years | 2018-12-31 | 2019-03-31 |
| Bupropion | WELLBUTRIN XL |
GLAXOSMITHKLINE (GSK) | 2010 | 3 years | 2018-12-31 | 2019-03-31 | |
| Liraglutide | Saxenda |
NOVO NORDISK | 2011 | 2009-06-30 | 3 years | 2018-12-31 | 2019-03-31 |
| Liraglutide | Victoza |
NOVO NORDISK | 2015 | 2009-06-30 | 3 years | 2018-12-31 | 2019-03-31 |