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 |
|---|---|---|---|---|---|---|---|
| Benzydamine Hydrochlride | UNITUM 7.5 mg/5 ml MOUTHWASH |
BATTERJEE PHARMACETICAL FACTORY | 2011 | 1964-07-10 | 3 years | 2018-10-31 | 2019-01-29 |
| Cinnarizine | STUGERON |
JANSSEN-CILAG | 2003 | 1961-11-01 | 3 years | 2018-10-31 | 2019-01-29 |
| Norgestimate/ Ethinylestradiol | CILEST |
JANSSEN-CILAG | 1997 | 1986-10-29 | 3 years | 2018-10-30 | 2019-01-28 |
| RITUXIMAB | Mabthera |
ROCHE | 2017 | 2097-11-26 | Annual | 2018-11-17 | 2019-01-26 |
| ERLOTINIB | Tarceva |
ROCHE | 2014 | 2004-11-18 | Annual | 2018-11-17 | 2019-01-26 |
| ATEZOLIZUMAB | Tecentriq |
ROCHE | 2017 | 2016-05-18 | 6 months | 2018-11-17 | 2019-01-26 |
| Calcium Polystyrene Sulphonate | Calcium Resonum |
SANOFI PASTEUR | 2000 | 1955-10-26 | 3 years | 2018-10-26 | 2019-01-24 |
| EPIRUBICIN HYDROCHLORIDE | EPIRUBICIN HCL |
SANDOZ | 2007 | 2002-12-18 | 3 Years | 2018-11-12 | 2019-01-21 |
| DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN |
SANDOZ | 2001 | 1993-08-20 | 3 Years | 2018-11-12 | 2019-01-21 |
| Human menopausal gonadotrophin (fsh, lh) | Merional |
IBSA INSTITUTE BIOCHIMIQUE S.A | 2000 | 2007-06-25 | 3 years | 2018-10-19 | 2019-01-17 |