Periodic safety reporting schedule

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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


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