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 |
---|---|---|---|---|---|---|---|
Turoctocog alfa | NovoEight 500 IU | NOVO NORDISK | annual | ||||
Deferasirox | Exjade Dispersible tablet | NOVARTIS | annual | ||||
Turoctocog alfa | NovoEight 1000 IU | NOVO NORDISK | annual | ||||
Turoctocog alfa | NovoEight 3000 IU | NOVO NORDISK | annual | ||||
Turoctocog alfa | NovoEight 1500 IU | NOVO NORDISK | annual | ||||
Turoctocog alfa | NovoEight 2000 IU | NOVO NORDISK | annual | ||||
Turoctocog alfa | NovoEight 250 IU | NOVO NORDISK | annual | ||||
Maprotiline hydrochloride | LUDIOMIL | AMDIPHARMA | 3 years | ||||
Etravirine 100mg | INTELENCE | JANSSEN-CILAG | 3 years | ||||
Micafungin | MYCAMINE | Jazeera Pharmaceutical Industries (JPI) | annual |