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 |
|---|---|---|---|---|---|---|---|
| Deferasirox | Exjade Dispersible tablet |
NOVARTIS | 2006 | 2005-11-02 | annual | 2017-10-31 | 2018-01-09 |
| Turoctocog alfa | NovoEight 1000 IU |
NOVO NORDISK | 2017 | 2013-10-15 | annual | 2017-10-31 | 2018-01-09 |
| Turoctocog alfa | NovoEight 1500 IU |
NOVO NORDISK | 2017 | 2013-10-15 | annual | 2017-10-31 | 2018-01-09 |
| Turoctocog alfa | NovoEight 2000 IU |
NOVO NORDISK | 2017 | 2013-10-15 | annual | 2017-10-31 | 2018-01-09 |
| Turoctocog alfa | NovoEight 250 IU |
NOVO NORDISK | 2017 | 2013-10-15 | annual | 2017-10-31 | 2018-01-09 |
| Turoctocog alfa | NovoEight 3000 IU |
NOVO NORDISK | 2017 | 2013-10-15 | annual | 2017-10-31 | 2018-01-09 |
| Turoctocog alfa | NovoEight 500 IU |
NOVO NORDISK | 2017 | 2013-10-15 | annual | 2017-10-31 | 2018-01-09 |
| Maprotiline hydrochloride | LUDIOMIL |
AMDIPHARMA | 2013 | 1970-09-23 | 3 years | 2017-09-30 | 2017-12-29 |
| Etravirine 100mg | INTELENCE |
JANSSEN-CILAG | 2010 | 2008-01-18 | 3 years | 2017-09-27 | 2017-12-26 |
| Micafungin | MYCAMINE |
Jazeera Pharmaceutical Industries (JPI) | 2007 | 2008-04-25 | annual | 2017-10-08 | 2017-12-17 |