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 |
---|---|---|---|---|---|---|---|
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 |