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
Benzydamine Hydrochlride UNITUM 5% GEL BATTERJEE PHARMACETICAL FACTORY 3 years
Cinnarizine STUGERON JANSSEN-CILAG 3 years
Norgestimate/ Ethinylestradiol CILEST JANSSEN-CILAG 3 years
RITUXIMAB Mabthera ROCHE Annual
ATEZOLIZUMAB Tecentriq ROCHE 6 months
ERLOTINIB Tarceva ROCHE Annual
Calcium Polystyrene Sulphonate Calcium Resonum SANOFI PASTEUR 3 years
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN SANDOZ 3 Years
EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HCL SANDOZ 3 Years
Human menopausal gonadotrophin (fsh, lh) Merional IBSA INSTITUTE BIOCHIMIQUE S.A 3 years


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