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 | 3 years | ||||
| Everolimus BHT | Afinitor | NOVARTIS | 3 years | ||||
| Fluconazole | DIFLUCAN | PFIZER | 3 Years | ||||
| MANNITOL | OSMITROL 10% INFUSION SOLN. | Baxter | 3 years | ||||
| Ibuprofen | Emifen 600 / 100mg/5ml | SANOFI PASTEUR | 3 years | ||||
| Ibuprofen | BRUFEN | ABBOTT Laboratories | 3 years | ||||
| Glucagon | GlucaGen 1mg | NOVO NORDISK | 3 years | ||||
| Glucagon | GlucaGen 1mg HypoKit | NOVO NORDISK | 3 years | ||||
| Haemophilus Influenza type B vaccine | Act-Hib | SANOFI PASTEUR | 3 years | ||||
| SALBUTAMOL, IPRATROPIUM BROMID | Combivent | BOEHRINGER INGELHEIM | 3 years |
