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 |
|---|---|---|---|---|---|---|---|
|
Mixture of dissolved insulin and isophane (NPH) insulin. |
Mixtard 40 Penfill | NOVO NORDISK | 3 years | ||||
| Human Insulin | Actrapid Penfill | NOVO NORDISK | 3 years | ||||
| Varicella vaccine (live) | VARILRIX | GLAXOSMITHKLINE (GSK) | 3 years | ||||
| Tadalafile | Cialis | Eli Lilly | 3 years | ||||
| Tadalafile | Cialis Once Daily | Eli Lilly | 3 years | ||||
| Levodopa + Carbidopa | DUODOPA intestinal gel | ABBVIE | 3 years | ||||
| Insulin degludec | Tresiba FlexTouch 200 | NOVO NORDISK | 3 years | ||||
| Insulin degludec/insulin aspart | Ryzodeg Penfill 100 IU/ml | NOVO NORDISK | 3 years | ||||
| Insulin degludec | Tresiba Penfill 100 | NOVO NORDISK | 3 years | ||||
| Insulin degludec | Tresiba FlexTouch 100 | NOVO NORDISK | 3 years |
