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 | Norditropin NordiLet 5mg | NOVO NORDISK | 3 years | ||||
| Somatropin | Norditropin NordiLet 15mg | NOVO NORDISK | 3 years | ||||
| Somatropin | Norditropin NordiLet 10mg | NOVO NORDISK | 3 years | ||||
| Temsirolimus | TORISEL | PFIZER | 3 Years | ||||
| Tacrolimus | ADVAGRAF | Jazeera Pharmaceutical Industries (JPI) | 3 years | ||||
| Somatropin | Norditropin SimpleXx 5 mg | NOVO NORDISK | 3 years | ||||
| Somatropin | Norditropin SimpleXx 15 mg | NOVO NORDISK | 3 years | ||||
| Somatropin | Norditropin SimpleXx 10 mg | NOVO NORDISK | 3 years | ||||
| Acarbose | Glucobay | BAYER PHARMA AG | 3 years | ||||
| Tacrolimus | PROGRAF | Hikma Pharmaceuticals PLC | 3 years |
