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 |
---|---|---|---|---|---|---|---|
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 |