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 |
|---|---|---|---|---|---|---|---|
| Eptacog alfa | NovoSeven 1mg |
NOVO NORDISK | 2011 | 1995-12-31 | 3 years | 2017-12-31 | 2018-03-31 |
| Eptacog alfa | NovoSeven 2mg |
NOVO NORDISK | 2011 | 1995-12-31 | 3 years | 2017-12-31 | 2018-03-31 |
| Eptacog alfa | NovoSeven 5mg |
NOVO NORDISK | 2011 | 1995-12-31 | 3 years | 2017-12-31 | 2018-03-31 |
| Celecoxib | CELEBREX |
PFIZER | 2000 | 1998-12-31 | 3 Years | 2017-12-31 | 2018-03-31 |
| Desmopressin | Minirin sublingual tablets |
FERRING | 2008 | 1972-12-06 | 3 years | 2017-12-31 | 2018-03-31 |
| Desmopressin | Minirin spray |
FERRING | 1998 | 1972-12-06 | 3 years | 2017-12-31 | 2018-03-31 |
| Ustekinumab | STELARA |
JANSSEN-CILAG | 2013 | 2008-12-31 | 3 years | 2017-12-31 | 2018-03-31 |
| Betahistine | BERTIGO |
Jazeera Pharmaceutical Industries (JPI) | 2012 | 3 years | 2017-12-31 | 2018-03-31 | |
| Dasabuvir | EXVIERA |
ABBVIE | 2015 | 2014-11-25 | annual | 2018-01-14 | 2018-03-25 |
| Ombitasvir/Paritaprevir/ritonavir | VIEKIRAX |
ABBVIE | 2015 | 2014-11-25 | annual | 2018-01-14 | 2018-03-25 |