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 |
---|---|---|---|---|---|---|---|
IRINOTECAN | IRINOTICAN EBEWE | SANDOZ | 3 Years | ||||
Valsartan | Diovan | NOVARTIS | 3 years | ||||
Valsartan/HCT | Co-Diovan Film-coated tablet 320/25 mg | NOVARTIS | 3 years | ||||
Valsartan/HCT | Co-Diovan Film-coated tablet 80/12.5 mg | NOVARTIS | 3 years | ||||
Valsartan/HCT | Co-Diovan Film-coated tablet 160/12.5 mg | NOVARTIS | 3 years | ||||
Valsartan/HCT | Co-Diovan Film-coated tablet 160/25 mg | NOVARTIS | 3 years | ||||
Valsartan/HCT | Co-Diovan Film-coated tablet 320/12.5 mg | NOVARTIS | 3 years | ||||
Paclitaxel | Paclitaxel | PFIZER | 3 Years | ||||
Gatifloxacin Sesquihydrate 0.5% | ZYMAXID eye drops solution | Allergan | 3 Years | ||||
Gatifloxacin 0.3% | Zymar Eye Drops | Allergan | 3 Years |