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 |
|---|---|---|---|---|---|---|---|
| BUDESONIDE, FORMOTEROL | SYMBICORT |
AstraZeneca | 2002 | 2000-08-24 | 3 years | 2019-08-24 | 2019-11-22 |
| Infliximab | REMICADE |
JANSSEN-CILAG | 2011 | 1998-08-24 | 3 years | 2019-08-23 | 2019-11-21 |
| Paricalcitol | ZEMPLAR |
ABBVIE | 2014 | 1998-04-17 | 3 years | 2019-08-17 | 2019-11-15 |
| Telbivudine | Sebivo |
NOVARTIS | 2007 | 2006-08-21 | 3 years | 2019-08-31 | 2019-11-09 |
| Oxcarbazepine | Trileptal |
NOVARTIS | 2002 | 1999-08-10 | 2 years | 2019-08-31 | 2019-11-09 |
| Agalsidase Beta | Fabrazyme |
SANOFI PASTEUR | 2016 | 2001-08-03 | 3 years | 2019-07-31 | 2019-10-29 |
| Catridecacog | NovoThirteen 2500 IU |
NOVO NORDISK | 2015 | 2012-07-31 | 3 years | 2019-07-31 | 2019-10-29 |
| Meloxicam | MELOXI |
JAMJOOM PHARMACEUTICALS COMPANY | 1997 | 1995-05-08 | 3 years | 2019-07-09 | 2019-10-08 |
| Meloxicam | meloxicam |
APM | 2005 | 1995-05-08 | 3 years | 2019-07-09 | 2019-10-07 |
| MELOXICAM | Mobic |
BOEHRINGER INGELHEIM | 1997 | 1995-05-08 | 3 years | 2019-07-09 | 2019-10-07 |