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
Mycophenolic acid Myfortic NOVARTIS annual
MYCOPHENOLATE MOFETIL Cellcept ROCHE Annual
Methylprednisolone DEPO MEDROL PFIZER 3 Years
POLYETHYLENE GLYCOL, PROPYLENE GLYCOL SYSTANE LUBRICANT EYE DROPS ALCON annual
PREDNISOLONE ACETATE OMNIPRED ALCON annual
Polyethylene Glycol Systane lid wipes ALCON annual
Polyethylene Glycol Systane Ultra UD ALCON annual
Polyethylene Glycol Systane Ultra MD ALCON annual
Polyethylene Glycol Systane Gel drops ALCON annual
OBINUTUZUMAB Gazyva ROCHE 6 months


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