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 |
|---|---|---|---|---|---|---|---|
| Insulin degludec/insulin aspart | Ryzodeg FlexTouch 100 IU/ml | NOVO NORDISK | 3 years | ||||
| Insulin degludec | Tresiba FlexTouch 100 | NOVO NORDISK | 3 years | ||||
| Insulin degludec | Tresiba Penfill 100 | NOVO NORDISK | 3 years | ||||
| Dinoprostone | Propess | FERRING | 3 years | ||||
| Alglucosidase alfa | Myozyme | SANOFI PASTEUR | 3 years | ||||
| Trabectedin | YONDELIS | JANSSEN-CILAG | 3 years | ||||
| Ranibizumab | Lucentis | NOVARTIS | 3 years | ||||
| Glycopyrronium Bromide | Seebri Breezhaler Inhalation powder | NOVARTIS | 3 years | ||||
| Drospirenone-Ethinylestradiol | Yasmin | BAYER PHARMA AG | 3 years | ||||
| Drospirenone-Ethinylestradiol-Levomefolate calcium | Yaz Plus Film-Coated | BAYER PHARMA AG | 3 years |
