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 |
|---|---|---|---|---|---|---|---|
| ISOFLURANE | AERRANE INHALATION ANAESTHITIC - 100mL | Baxter | 3 years | ||||
| Insulin detemir | Levemir Penfill | NOVO NORDISK | 3 years | ||||
| Insulin detemir | Levemir FlexPen | NOVO NORDISK | 3 years | ||||
| Isoflurane | FLORAN | Hikma Pharmaceuticals PLC | 3 years | ||||
|
Mixture of dissolved insulin and isophane (NPH) insulin. |
Mixtard 40 Penfill | NOVO NORDISK | 3 years | ||||
|
Suspension of isophane (NPH) insulin. |
Insulatard Penfill | NOVO NORDISK | 3 years | ||||
| Human Insulin | Actrapid Penfill | NOVO NORDISK | 3 years | ||||
|
Suspension of isophane (NPH) insulin. |
Insulatard vial | NOVO NORDISK | 3 years | ||||
|
Mixture of dissolved insulin and isophane (NPH) insulin. |
Mixtard 30 vial | NOVO NORDISK | 3 years | ||||
|
Mixture of dissolved insulin and isophane (NPH) insulin. |
Mixtard 50 Penfill | NOVO NORDISK | 3 years |
