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
Pazopanib Votrient NOVARTIS annual
CEFTAZIDIME PARZIDIME SANDOZ 3 Years
Carbidopa/Entacapone/Levodopa Stalevo NOVARTIS 3 years
Bromocriptine Parlodel Tablet NOVARTIS 3 years
Nintedanib Ofev BOEHRINGER INGELHEIM annual
Hepatitis a (inactivated) / hepatitis b (rdna) vaccines (adsorbed) TWINRIX ADULT MONODOSE GLAXOSMITHKLINE (GSK) 3 years
Oseltamivir OSELTA JAMJOOM PHARMACEUTICALS COMPANY 3 years
OSELTAMIVIR Tamiflu ROCHE 3 years
Adefovir HEPSERA GLAXOSMITHKLINE (GSK) 3 years
Filgrastim Neupogen AMGEN 3 years


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