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 |
|---|---|---|---|---|---|---|---|
| Oral Bivalent Types 1 and 3 Poliomyelitis Vaccine | 3 Poliomyelitis Vaccine [Oral Bivalent Types 1 and] |
SANOFI PASTEUR | 2016 | 2011-07-26 | annual | 2018-07-15 | 2018-09-23 |
| Oral poliomyelitis vaccine | OPVero |
SANOFI PASTEUR | 2000 | 1988-08-16 | annual | 2018-07-15 | 2018-09-23 |
| IBANDRONIC ACID | Bonviva |
ROCHE | 2016 | 2096-06-25 | 3 years | 2018-06-24 | 2018-09-22 |
| Alirocumab | Praluent |
SANOFI PASTEUR | 2018 | 2015-07-24 | 6 months | 2018-07-24 | 2018-09-22 |
| Atazanavir | Reyataz |
BRISTOL-MYERS SQUIBB | 2010 | 2003-06-20 | 3 years | 2018-06-19 | 2018-09-17 |
| Cabazitaxel | Jevtana |
SANOFI PASTEUR | 2016 | 2010-06-17 | 3 year | 2018-06-17 | 2018-09-16 |
| Glibenclamide + Metformin | Daonil M |
SANOFI PASTEUR | 2012 | 1993-06-18 | 3 years | 2018-06-18 | 2018-09-16 |
| PEGINTERFERON ALFA-2A | Pegasys |
ROCHE | 2003 | 2001-07-05 | 3 years | 2018-07-04 | 2018-09-12 |
| ALECTINIB | Alecensa |
ROCHE | 2017 | 2014-07-04 | 6 months | 2018-07-03 | 2018-09-11 |
| Daclatasvir | Daklinza |
BRISTOL-MYERS SQUIBB | 2015 | 2014-07-04 | annual | 2018-07-03 | 2018-09-11 |