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
Nivolumab Opdivo BRISTOL-MYERS SQUIBB 6 months
brinzolamide, brimonidine Simbrinza ALCON annual
Canakinumab Ilaris NOVARTIS 3 years
BALANCED SALT SOLUTION EYE STREAM SOLN ALCON annual
ACYCLOVIR MEDVIROX 5% CREAM MEDPHARMA PHARMACEUTICAL & CHEMICAL INDUSTRIES 3 years
Acyclovir 5% Cream CIVAR Pharma International Co 3 years
Aciclovir Aciclovir PFIZER 3 Years
Aciclovir ZOVIRAX GLAXOSMITHKLINE (GSK) 3 years
Daunorubicin Hydrochloride Daunorubicin Hydrochloride PFIZER 3 Years
DASATINIB sprycel BRISTOL-MYERS SQUIBB annual


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