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 |
---|---|---|---|---|---|---|---|
CILAZAPRIL AND CILAZAPRIL + HYDROCHLOROTHIAZOLE | Inhibace and inhibace plus | ROCHE | 3 years | ||||
Amlodipine | Glodip | SANOFI PASTEUR | annual | ||||
EPOETIN BETA | Neorecormon | ROCHE | 3 years | ||||
TRAVOPROST, TIMOLOL | DUOTRAV EYE DROPS | ALCON | annual | ||||
CYCLOPENTOLATE | CYCLOGYL EYE DROPS 1% | ALCON | annual | ||||
TRAVOPROST | TRAVATAN EYE DROP | ALCON | annual | ||||
Nepafenac | Nevanac | ALCON | annual | ||||
Vildagliptin | Galvus | NOVARTIS | 3 years | ||||
Metformin/Vildagliptin | Eucreas | NOVARTIS | 3 years | ||||
Fingolimod hydrochloride | Gilenya | NOVARTIS | annual |