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 |
|---|---|---|---|---|---|---|---|
| Nivolumab | Opdivo |
BRISTOL-MYERS SQUIBB | 2015 | 2014-07-04 | 6 months | 2018-07-03 | 2018-09-11 |
| BALANCED SALT SOLUTION | EYE STREAM SOLN |
ALCON | 1986 | 1969-12-31 | annual | 2018-06-30 | 2018-09-08 |
| brinzolamide, brimonidine | Simbrinza |
ALCON | 2017 | 2013-04-19 | annual | 2018-06-30 | 2018-09-08 |
| Canakinumab | Ilaris |
NOVARTIS | 2013 | 2009-06-17 | 3 years | 2018-06-30 | 2018-09-08 |
| Aciclovir | ZOVIRAX |
GLAXOSMITHKLINE (GSK) | 1987 | 1981-10-06 | 3 years | 2018-06-09 | 2018-09-07 |
| ACYCLOVIR | MEDVIROX 5% CREAM |
MEDPHARMA PHARMACEUTICAL & CHEMICAL INDUSTRIES | 2008 | 1981-06-10 | 3 years | 2018-06-09 | 2018-09-07 |
| Aciclovir | Aciclovir |
PFIZER | 1999 | 1996-08-19 | 3 Years | 2018-06-09 | 2018-09-07 |
| Acyclovir 5% Cream | CIVAR |
Pharma International Co | 2010 | 1981-10-06 | 3 years | 2018-06-09 | 2018-09-07 |
| DASATINIB | sprycel |
BRISTOL-MYERS SQUIBB | 2008 | 2006-06-28 | annual | 2018-06-27 | 2018-09-05 |
| Daunorubicin Hydrochloride | Daunorubicin Hydrochloride |
PFIZER | 1988 | 1966-06-08 | 3 Years | 2018-06-07 | 2018-09-05 |