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 | annual | ||||
| Oral poliomyelitis vaccine | OPVero | SANOFI PASTEUR | annual | ||||
| IBANDRONIC ACID | Bonviva | ROCHE | 3 years | ||||
| Alirocumab | Praluent | SANOFI PASTEUR | 6 months | ||||
| Atazanavir | Reyataz | BRISTOL-MYERS SQUIBB | 3 years | ||||
| Glibenclamide + Metformin | Daonil M | SANOFI PASTEUR | 3 years | ||||
| Cabazitaxel | Jevtana | SANOFI PASTEUR | 3 year | ||||
| PEGINTERFERON ALFA-2A | Pegasys | ROCHE | 3 years | ||||
| ALECTINIB | Alecensa | ROCHE | 6 months | ||||
| Daclatasvir | Daklinza | BRISTOL-MYERS SQUIBB | annual |
