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 |
---|---|---|---|---|---|---|---|
Olanzapine | Zyprexa Tab 10 | Eli Lilly | 3 years | ||||
Olanzapine | Zyprexa IM | Eli Lilly | 3 years | ||||
Olanzapine | PRANZA | Jazeera Pharmaceutical Industries (JPI) | 3 years | ||||
Olanzapine pamoate | Zypadhera 210 | Eli Lilly | 3 years | ||||
Cytarabine | CYTOSAR | PFIZER | 2 Years | ||||
Telaprevir | INCIVO | JANSSEN-CILAG | 3 years | ||||
Alprazolam | XANAX | PFIZER | 3 Years | ||||
RECOMBINANT SOMATROPIN | OMNITROPE | SANDOZ | 2 Years | ||||
CYTARABINE | ALEXAN | SANDOZ | 2 Years | ||||
Vardenafil | LEVITRA | BAYER PHARMA AG | 3 years |