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 |
---|---|---|---|---|---|---|---|
BUSULPHAN | BUSULPHAN | ASPEN | 3 years | ||||
Chlorthalidone | HYGROTON | AMDIPHARMA | 3 years | ||||
Paliperidone | INVEGA | JANSSEN-CILAG | 3 years | ||||
Belatacept | Nulojix | BRISTOL-MYERS SQUIBB | 3 years | ||||
MITOXANTRONE HYDROCHLORIDE | MITOXANTRON EBEWE | SANDOZ | 3 Years | ||||
Moxifloxacin | MAXIM | JAMJOOM PHARMACEUTICALS COMPANY | 3 years | ||||
Loperamide | IMODIUx | JANSSEN-CILAG | 3 years | ||||
Tirofiban | Aggrastat | Algorithm | 3 years | ||||
Moxifloxacin | Avalox | BAYER PHARMA AG | 3 years | ||||
Fusidic acid, Betamethasone | FUSIZONE | BATTERJEE PHARMACETICAL FACTORY | 3 years |