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
AMPICILLIN STANDACILLIN SANDOZ 3 Years
Voriconazole VFEND PFIZER annual
PIRFENIDONE Esbriet ROCHE Annual
BEVACIZUMAB Avastin ROCHE Annual
Pemetrexed Alimta 500 mg Eli Lilly 3 years
COBIMETINIB Cotellic ROCHE 6 months
Ruxolitinib Jakavi NOVARTIS annual
TRASTUZUMAB EMTANSINE Kadcyla ROCHE Annual
Atosiban Tractocile FERRING 3 years
MEFLOQUINE Lariam ROCHE 3 years


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