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
CILAZAPRIL AND CILAZAPRIL + HYDROCHLOROTHIAZOLE Inhibace and inhibace plus ROCHE 3 years
Amlodipine Glodip SANOFI PASTEUR annual
EPOETIN BETA Neorecormon ROCHE 3 years
TRAVOPROST, TIMOLOL DUOTRAV EYE DROPS ALCON annual
CYCLOPENTOLATE CYCLOGYL EYE DROPS 1% ALCON annual
TRAVOPROST TRAVATAN EYE DROP ALCON annual
Nepafenac Nevanac ALCON annual
Vildagliptin Galvus NOVARTIS 3 years
Metformin/Vildagliptin Eucreas NOVARTIS 3 years
Fingolimod hydrochloride Gilenya NOVARTIS annual


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