Periodic safety reporting schedule
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 | 1999 | 1988-03-01 | 3 years | 2019-10-26 | 2020-01-24 |
| Mixture of dissolved insulin and isophane (NPH) insulin. |
Mixtard 50 Penfill |
NOVO NORDISK | 1999 | 1988-03-01 | 3 years | 2019-10-26 | 2020-01-24 |
| Varicella vaccine (live) | VARILRIX |
GLAXOSMITHKLINE (GSK) | 1999 | 1994-10-17 | 3 years | 2019-10-17 | 2020-01-15 |
| Tadalafile | Cialis |
Eli Lilly | 2003 | 2002-10-15 | 3 years | 2019-10-15 | 2020-01-13 |
| Tadalafile | Cialis Once Daily |
Eli Lilly | 2012 | 2012-10-15 | 3 years | 2019-10-15 | 2020-01-13 |
| Levodopa + Carbidopa | DUODOPA intestinal gel |
ABBVIE | 2016 | 2004-01-21 | 3 years | 2019-10-01 | 2019-12-30 |
| Insulin degludec | Tresiba FlexTouch 100 |
NOVO NORDISK | 2015 | 2012-09-28 | 3 years | 2019-09-30 | 2019-12-29 |
| Insulin degludec | Tresiba FlexTouch 200 |
NOVO NORDISK | 2015 | 2012-09-28 | 3 years | 2019-09-30 | 2019-12-29 |
| Insulin degludec | Tresiba Penfill 100 |
NOVO NORDISK | 2015 | 2012-09-28 | 3 years | 2019-09-30 | 2019-12-29 |
| Insulin degludec/insulin aspart | Ryzodeg FlexTouch 100 IU/ml |
NOVO NORDISK | 2017 | 2012-09-28 | 3 years | 2019-09-30 | 2019-12-29 |