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 |
|---|---|---|---|---|---|---|---|
| Somatropin | GENOTROPIN |
PFIZER | 1995 | 1987-03-27 | 3 years | 2020-03-31 | 2020-06-29 |
| Everolimus BHT | Afinitor |
NOVARTIS | 2011 | 2009-03-30 | 3 years | 2020-03-31 | 2020-06-09 |
| Fluconazole | DIFLUCAN |
PFIZER | 1993 | 1988-03-08 | 3 Years | 2017-03-02 | 2020-05-31 |
| MANNITOL | OSMITROL 10% INFUSION SOLN. |
Baxter | 1998 | 1964-06-08 | 3 years | 2020-02-28 | 2020-05-28 |
| Ibuprofen | BRUFEN |
ABBOTT Laboratories | 1981 | 3 years | 2020-02-18 | 2020-05-18 | |
| Ibuprofen | Emifen 600 / 100mg/5ml |
SANOFI PASTEUR | 1905 | 1983-10-14 | 3 years | 2020-02-18 | 2020-05-18 |
| Glucagon | GlucaGen 1mg |
NOVO NORDISK | 1998 | 1989-09-18 | 3 years | 2020-02-14 | 2020-05-14 |
| Glucagon | GlucaGen 1mg HypoKit |
NOVO NORDISK | 1998 | 1989-09-18 | 3 years | 2020-02-14 | 2020-05-14 |
| Haemophilus Influenza type B vaccine | Act-Hib |
SANOFI PASTEUR | 1996 | 1992-02-06 | 3 years | 2020-02-06 | 2020-05-07 |
| SALBUTAMOL, IPRATROPIUM BROMID | Combivent |
BOEHRINGER INGELHEIM | 1998 | 1994-03-22 | 3 years | 2020-01-31 | 2020-04-30 |