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
Cabergoline DOSTINEX PFIZER 3 Years
Sildenafil Citrate VIAGRA PFIZER 3 Years
Canagliflozin INVOKANA JANSSEN-CILAG Annual
Bimatoprost Lumigan Eye Drops Allergan 3 Years
OCRELIZUMAB Ocrevus ROCHE 6 months
Meningococcal group a, c, w135, y polysaccharide vaccine Menveo GLAXOSMITHKLINE (GSK) 3 years
Ipilimumab Yervoy BRISTOL-MYERS SQUIBB annual
hydroxyethyl starch 6% (HES 130/0.4) in normal saline solution Voluven 6% IV infusion FRESENIUS KABI Annual
Dobutamine Hydrochloride Dobutamine Hydrochloride PFIZER 3 Years
Dobutamine DOBUTAMINE Jazeera Pharmaceutical Industries (JPI) 3 years


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