Periodic safety reporting schedule
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 |