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 aspart | NovoMix 30 Penfill |
NOVO NORDISK | 2003 | 1999-09-30 | 3 years | 2018-09-30 | 2018-12-29 |
| Insulin aspart | NovoMix 50 FlexPen |
NOVO NORDISK | 2014 | 1999-09-30 | 3 years | 2018-09-30 | 2018-12-29 |
| Insulin aspart | NovoMix 50 Penfill |
NOVO NORDISK | 2014 | 1999-09-30 | 3 years | 2018-09-30 | 2018-12-29 |
| Insulin aspart | NovoMix 70 FlexPen |
NOVO NORDISK | 2014 | 1999-09-30 | 3 years | 2018-09-30 | 2018-12-29 |
| Insulin aspart | NovoMix 70 Penfill |
NOVO NORDISK | 2014 | 1999-09-30 | 3 years | 2018-09-30 | 2018-12-29 |
| Insulin aspart | NovoRapid FlexPen |
NOVO NORDISK | 2004 | 1999-09-30 | 3 years | 2018-09-30 | 2018-12-29 |
| Insulin aspart | NovoRapid Penfill |
NOVO NORDISK | 2004 | 1999-09-30 | 3 years | 2018-09-30 | 2018-12-29 |
| Diclofenac potassium | DOLVIC- K |
Pharma International Co | 2008 | 1977-11-05 | 3 years | 2018-09-30 | 2018-12-29 |
| Diclofenac (systemic formulations) | DICLOMAX |
Jazeera Pharmaceutical Industries (JPI) | 1999 | 1977-11-05 | 3 years | 2018-09-30 | 2018-12-29 |
| Diclofenac (topical formulations) | DICLOMAX |
Jazeera Pharmaceutical Industries (JPI) | 2003 | 1977-11-05 | 3 years | 2018-09-30 | 2018-12-29 |