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 |
---|---|---|---|---|---|---|---|
AMPICILLIN | STANDACILLIN | SANDOZ | 3 Years | ||||
Voriconazole | VFEND | PFIZER | annual | ||||
PIRFENIDONE | Esbriet | ROCHE | Annual | ||||
BEVACIZUMAB | Avastin | ROCHE | Annual | ||||
Pemetrexed | Alimta 500 mg | Eli Lilly | 3 years | ||||
COBIMETINIB | Cotellic | ROCHE | 6 months | ||||
Ruxolitinib | Jakavi | NOVARTIS | annual | ||||
TRASTUZUMAB EMTANSINE | Kadcyla | ROCHE | Annual | ||||
Atosiban | Tractocile | FERRING | 3 years | ||||
MEFLOQUINE | Lariam | ROCHE | 3 years |