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 |
---|---|---|---|---|---|---|---|
Mycophenolic acid | Myfortic | NOVARTIS | annual | ||||
MYCOPHENOLATE MOFETIL | Cellcept | ROCHE | Annual | ||||
Methylprednisolone | DEPO MEDROL | PFIZER | 3 Years | ||||
POLYETHYLENE GLYCOL, PROPYLENE GLYCOL | SYSTANE LUBRICANT EYE DROPS | ALCON | annual | ||||
PREDNISOLONE ACETATE | OMNIPRED | ALCON | annual | ||||
Polyethylene Glycol | Systane lid wipes | ALCON | annual | ||||
Polyethylene Glycol | Systane Ultra UD | ALCON | annual | ||||
Polyethylene Glycol | Systane Ultra MD | ALCON | annual | ||||
Polyethylene Glycol | Systane Gel drops | ALCON | annual | ||||
OBINUTUZUMAB | Gazyva | ROCHE | 6 months |