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
Palivizumab SYNAGIS ABBVIE 3 year

BUPRENOPHINE
BUTRANS NAPP PHARMACEUTICALS LIMITED 3 years
Spironolactone ALDACTONE PFIZER 3 Years
Tigecycline TYGACIL PFIZER 3 Years
Octreotide Sandostatin LAR NOVARTIS 3 years
Octreotide Sandostatin NOVARTIS 3 years
Oxytocin Syntocinon NOVARTIS 3 years
METHOTREXATE METHOTREXATE "EBEWE SANDOZ 3 Years
TETRACOSACTIDE SYNACTHEN DEPOT MALLINCKRODT SPECIALTY PHARMACEUTICALS 3 years
Varenicline Tartrate CHAMPIX PFIZER 3 Years


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