Periodic safety reporting schedule
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 5 |
Eli Lilly | 2008 | 1996-09-27 | 3 years | 2019-03-31 | 2019-06-29 |
| Olanzapine | Zyprexa Tab 10 |
Eli Lilly | 1998 | 1996-09-27 | 3 years | 2019-03-31 | 2019-06-29 |
| Olanzapine | Zyprexa IM |
Eli Lilly | 2006 | 1997-09-27 | 3 years | 2019-03-31 | 2019-06-29 |
| Olanzapine pamoate | Zypadhera 210 |
Eli Lilly | 2010 | 2008-11-19 | 3 years | 2019-03-31 | 2019-06-29 |
| Cytarabine | CYTOSAR |
PFIZER | 1997 | 1969-04-17 | 2 Years | 2017-03-31 | 2019-06-29 |
| Telaprevir | INCIVO |
JANSSEN-CILAG | 2013 | 2011-05-23 | 3 years | 2019-03-19 | 2019-06-17 |
| RECOMBINANT SOMATROPIN | OMNITROPE |
SANDOZ | 2014 | 2004-09-29 | 2 Years | 2019-03-31 | 2019-06-09 |
| CYTARABINE | ALEXAN |
SANDOZ | 2006 | 2006-05-08 | 2 Years | 2019-03-31 | 2019-06-09 |
| Alprazolam | XANAX |
PFIZER | 1992 | 1980-03-12 | 3 Years | 2019-03-11 | 2019-06-09 |
| Vardenafil | LEVITRA |
BAYER PHARMA AG | 2004 | 2003-03-04 | 3 years | 2019-03-04 | 2019-06-02 |