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 |
|---|---|---|---|---|---|---|---|
| Insulin detemir | Levemir FlexPen |
NOVO NORDISK | 2005 | 2003-11-01 | 3 years | 2019-10-31 | 2020-01-29 |
| Insulin detemir | Levemir Penfill |
NOVO NORDISK | 2005 | 2003-11-01 | 3 years | 2019-10-31 | 2020-01-29 |
| OROS Methylphenidate Hydrochloride | CONCERTA |
JANSSEN-CILAG | 2005 | 2000-08-01 | 3 years | 2019-10-31 | 2020-01-29 |
| ISOFLURANE | AERRANE INHALATION ANAESTHITIC - 100mL |
Baxter | 2002 | 1981-07-10 | 3 years | 2019-10-31 | 2020-01-29 |
| Human Insulin | Actrapid Penfill |
NOVO NORDISK | 1989 | 1988-03-01 | 3 years | 2019-10-26 | 2020-01-24 |
| Human Insulin | Actrapid vial |
NOVO NORDISK | 1989 | 1988-03-01 | 3 years | 2019-10-26 | 2020-01-24 |
| Suspension of isophane (NPH) insulin. |
Insulatard Penfill |
NOVO NORDISK | 1989 | 1988-03-01 | 3 years | 2019-10-26 | 2020-01-24 |
| Suspension of isophane (NPH) insulin. |
Insulatard vial |
NOVO NORDISK | 1989 | 1988-03-01 | 3 years | 2019-10-26 | 2020-01-24 |
| Mixture of dissolved insulin and isophane (NPH) insulin. |
Mixtard 30 Penfill |
NOVO NORDISK | 1989 | 1988-03-01 | 3 years | 2019-10-26 | 2020-01-24 |
| Mixture of dissolved insulin and isophane (NPH) insulin. |
Mixtard 30 vial |
NOVO NORDISK | 1989 | 1988-03-01 | 3 years | 2019-10-26 | 2020-01-24 |