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 |
---|---|---|---|---|---|---|---|
TELMISARTAN, AMLODIPINE | Twynsta | BOEHRINGER INGELHEIM | 3 years | ||||
VEMURAFENIB | Zelboraf | ROCHE | Annual | ||||
Tiapride | Tiapridal | SANOFI PASTEUR | 3 years | ||||
Interferon beta-1b | Betaferon | BAYER PHARMA AG | 3 years | ||||
Alprostadil | Prostin | PFIZER | 3 Years | ||||
Nonacog Alfa | Nonacog Alfa | PFIZER | annual | ||||
Palbociclib | IBRANCE | PFIZER | 6 Months | ||||
NAPHAZOLINE HYDROCHLORIDE, PHENIRAMINE MALEATE | NAPHCON-A EYE DROPS | ALCON | annual | ||||
NAPHAZOLINE HYDROCHLORIDE | NAPHCON FORTE 0.1% EYE DROPS | ALCON | annual | ||||
METFORMIN HEXAL | METFORMIN HEXAL | SANDOZ | 2 Years |