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 |
|---|---|---|---|---|---|---|---|
| Mepolizumab | NUCALA |
GLAXOSMITHKLINE (GSK) | 2017 | 2015-12-02 | 6 months | 2017-03-23 | 2017-06-01 |
| Fluconazole | fluconazole |
APM | 2003 | 1988-03-03 | 3 years | 2017-03-02 | 2017-05-31 |
| Fuconazole (Injection) | FLUCAND |
Hikma Pharmaceuticals PLC | 2003 | 1988-03-03 | 3 years | 2017-03-02 | 2017-05-31 |
| Fluconazole | FLUCORAL |
Jazeera Pharmaceutical Industries (JPI) | 2006 | 1988-03-03 | 3 years | 2017-03-02 | 2017-05-31 |
| IBUPROFEN | MEDAFEN 100MG-5ML SUSPENSION |
MEDPHARMA PHARMACEUTICAL & CHEMICAL INDUSTRIES | 2006 | 2008-10-23 | 3 years | 2017-02-18 | 2017-05-19 |
| Belimumab | BENLYSTA |
GLAXOSMITHKLINE (GSK) | 2013 | 2011-07-13 | annual | 2017-03-08 | 2017-05-17 |
| Amlodipine | amlodipine |
APM | 2005 | 1989-08-03 | 3 years | 2017-03-07 | 2017-05-16 |
| Haemophilus type b conjugate vaccines | haemophilus type b conjugate vaccines |
GLAXOSMITHKLINE (GSK) | 2000 | 1992-02-06 | 3 years | 2017-02-06 | 2017-05-07 |
| Levosalbutamol, salbutamol | VENTOLIN |
GLAXOSMITHKLINE (GSK) | 1981 | 1969-01-31 | 3 years | 2017-01-31 | 2017-05-01 |
| Fluconazole | DURACAN |
JAMJOOM PHARMACEUTICALS COMPANY | 1999 | 1988-03-03 | 3 years | 2017-03-02 | 2017-05-01 |