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 |
|---|---|---|---|---|---|---|---|
| Diclofenac sodium | Flector tissugel |
IBSA INSTITUTE BIOCHIMIQUE S.A | 2003 | 1977-11-05 | 3 years | 2018-09-30 | 2018-12-29 |
| diclofenac (systemic formulations,injection) | VOTREX |
Hikma Pharmaceuticals PLC | 1993 | 1977-11-05 | 3 years | 2018-09-30 | 2018-12-29 |
| Diclofenac Sodium | VOTREX |
Hikma Pharmaceuticals PLC | 1996 | 1977-11-05 | 3 years | 2018-09-30 | 2018-12-29 |
| Diclofenac (topical formulations) | diclofenac |
GLAXOSMITHKLINE (GSK) | 1992 | 1977-11-05 | 3 years | 2018-09-30 | 2018-12-29 |
| DICLOFENAC SODIUM | DICLON 1% EMULGEL |
MEDPHARMA PHARMACEUTICAL & CHEMICAL INDUSTRIES | 2006 | 1977-05-11 | 3 years | 2018-09-30 | 2018-12-29 |
| Diclofenac Epolamin | FLECTOR EP TISSUGEL 1GM PATCHES |
IBSA INSTITUTE BIOCHIMIQUE S.A | 2003 | 1993-06-25 | 3 years | 2018-09-30 | 2018-12-29 |
| Irbesartan/HCTZ | CoAprovel |
SANOFI PASTEUR | 2009 | 1997-09-30 | 3 years | 2018-09-30 | 2018-12-29 |
| Irbesartan | APROVEL |
SANOFI PASTEUR | 2002 | 1997-08-12 | 3 years | 2018-09-30 | 2018-12-29 |
| Diclofenac sodium | Emifenac 50 DT |
SANOFI PASTEUR | 1905 | 1984-10-31 | 3 years | 2018-09-30 | 2018-12-29 |
| Insulin aspart | NovoMix 30 FlexPen |
NOVO NORDISK | 2004 | 1999-09-30 | 3 years | 2018-09-30 | 2018-12-29 |