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
IRINOTECAN IRINOTICAN EBEWE SANDOZ 3 Years
Valsartan Diovan NOVARTIS 3 years
Valsartan/HCT Co-Diovan Film-coated tablet 320/25 mg NOVARTIS 3 years
Valsartan/HCT Co-Diovan Film-coated tablet 80/12.5 mg NOVARTIS 3 years
Valsartan/HCT Co-Diovan Film-coated tablet 160/12.5 mg NOVARTIS 3 years
Valsartan/HCT Co-Diovan Film-coated tablet 160/25 mg NOVARTIS 3 years
Valsartan/HCT Co-Diovan Film-coated tablet 320/12.5 mg NOVARTIS 3 years
Paclitaxel Paclitaxel PFIZER 3 Years
Gatifloxacin Sesquihydrate 0.5% ZYMAXID eye drops solution Allergan 3 Years
Gatifloxacin 0.3% Zymar Eye Drops Allergan 3 Years


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