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
ATEZOLIZUMAB Tecentriq ROCHE 6 months
Bortezomib VELCADE JANSSEN-CILAG 3 years
Fluticasone furoate AVAMYS GLAXOSMITHKLINE (GSK) 3 years
Imatinib mesilate Glivec NOVARTIS 3 years
Ofloxacin OPTIFLOX JAMJOOM PHARMACEUTICALS COMPANY 3 years
ISOTRETINOIN Roaccutane ROCHE Annual
Ofloxacin 0.3% Oflox Eye Drops Allergan 3 Year
Ofloxacin Tarivid SANOFI PASTEUR 3years
Tofacitinib Citrate XELJANZ PFIZER 6 Months

FLUTICASONE PROPIONATE/FORMOTEROL FUMERATE
FLUTIFORM NAPP PHARMACEUTICALS LIMITED annual


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