Periodic safety reporting schedule

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Active Substances Trade Name MAH Year of registration in Saudi Arabia International Birth Date (IBD) PSUR Submission Frequency Data Lock Point (DLP) Submission Date
Prucalopride Succinate RESOLOR JANSSEN-CILAG 3 years
Abatacept Orencia POWDER FOR SOLUTION FOR INFUSION BRISTOL-MYERS SQUIBB 3 years
Abatacept Orencia pre-filled syringe BRISTOL-MYERS SQUIBB 3 years
Idarubicin Hydrochloride ZAVEDOS PFIZER 3 Years
Docetaxel Taxotere SANOFI PASTEUR 3 years
Docetaxel Docetaxel PFIZER 3 Years
Domperidone DOMPY JAMJOOM PHARMACEUTICALS COMPANY 3 years
Domperidone MOTILIUM JANSSEN-CILAG 3 years
Clopidogrel Plavix SANOFI PASTEUR 3 years
Isoflurane FLORAN Hikma Pharmaceuticals PLC 3 years


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