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 |
|---|---|---|---|---|---|---|---|
| Diphtheria / tetanus / pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin) (acellular, component) / hepatitis b (rdna) / poliomyelitis (inactivated) / haemophilus type b conjugate vaccines (adsorbed) | INFANRIX |
GLAXOSMITHKLINE (GSK) | 2005 | 2000-10-23 | 3 years | 2017-10-22 | 2018-01-20 |
| 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 |