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
BUSULPHAN BUSULPHAN ASPEN 3 years
Chlorthalidone HYGROTON AMDIPHARMA 3 years
Paliperidone INVEGA JANSSEN-CILAG 3 years
Belatacept Nulojix BRISTOL-MYERS SQUIBB 3 years
MITOXANTRONE HYDROCHLORIDE MITOXANTRON EBEWE SANDOZ 3 Years
Moxifloxacin MAXIM JAMJOOM PHARMACEUTICALS COMPANY 3 years
Loperamide IMODIUx JANSSEN-CILAG 3 years
Tirofiban Aggrastat Algorithm 3 years
Moxifloxacin Avalox BAYER PHARMA AG 3 years
Fusidic acid, Betamethasone FUSIZONE BATTERJEE PHARMACETICAL FACTORY 3 years


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