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 |
|---|---|---|---|---|---|---|---|
| Ketotifen | Gloditen 1mg tablets |
SANOFI PASTEUR | 2005 | 1990-10-20 | 3 years | 2017-10-31 | 2018-01-29 |
| Darbepoetin Alfa | Aranesp |
AMGEN | 2006 | 2001-05-16 | 3 years | 2017-10-31 | 2018-01-29 |
| Human Insulin | Humulin N 100 Iuml/ml 10 ml |
Eli Lilly | 1985 | 1980-10-26 | 3 years | 2017-10-26 | 2018-01-26 |
| Human Insulin | Humulin R 100 IU/ml 10 ml |
Eli Lilly | 1985 | 1980-10-26 | 3 years | 2017-10-26 | 2018-01-26 |
| Human Insulin | Humulin 70/30 100 IU/ml 10 ml |
Eli Lilly | 1992 | 1980-10-26 | 3 years | 2017-10-26 | 2018-01-26 |
| Human Insulin | Humulin N Cartridges |
Eli Lilly | 2002 | 1980-10-26 | 3 years | 2017-10-26 | 2018-01-26 |
| Human Insulin | Humulin R Cartrides |
Eli Lilly | 2002 | 1980-10-26 | 3 years | 2017-10-26 | 2018-01-26 |
| Human Insulin | Humulin 70/30 Cartridges |
Eli Lilly | 2002 | 1980-10-26 | 3 years | 2017-10-26 | 2018-01-26 |
| Daratumumab | DARZALEX |
JANSSEN-CILAG | 2017 | 2015-11-16 | 6 months | 2017-11-15 | 2018-01-24 |
| Diphtheria / tetanus / pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin) (acellular, component) / hepatitis b (rdna) / poliomyelitis (inactivated) / haemophilus type b conjugate vaccines (adsorbed) | INFANRIX |
GLAXOSMITHKLINE (GSK) | 2005 | 2000-10-23 | 3 years | 2017-10-22 | 2018-01-20 |