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 |
---|---|---|---|---|---|---|---|
Bendamustin Hydrochloride | RIBOMUSTIN | ASTELLAS PHARMA | annual | ||||
ALECTINIB | Alecensa | ROCHE | 6 months | ||||
Tobramycin | Tobi Podhaler | NOVARTIS | 2 years | ||||
Omalizumab | Xolair | NOVARTIS | annual | ||||
ALLOPURINOL | ZYLORIC | ASPEN | 3 years | ||||
PHYTOMENADION | Konakion | ROCHE | 3 years | ||||
PHENYLEPHRINE HYDROCHLORIDE | MYDFRIN 2.5% DROPS | ALCON | annual | ||||
TICAGRELOR | BRILINTA | AstraZeneca | 1 year | ||||
Lenalidomide | Revlimid | Algorithm | annual | ||||
Secukinumab | Cosentyx | NOVARTIS | annual |