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 |
|---|---|---|---|---|---|---|---|
| Ceftazidime | FORTUM |
GLAXOSMITHKLINE (GSK) | 1987 | 3 years | 2018-10-17 | 2019-01-15 | |
| Ceftazidime | FORTA-Z |
Jazeera Pharmaceutical Industries (JPI) | 2016 | 3 years | 2018-10-17 | 2019-01-15 | |
| CLINDAMYCIN PHOSPHATE | MEDACIN -T 1% GEL |
MEDPHARMA PHARMACEUTICAL & CHEMICAL INDUSTRIES | 2008 | 1995-09-22 | 3 years | 2018-10-15 | 2019-01-13 |
| CLINDAMYCIN PHOSPHATE | MEDACIN -T 1% TOPICAL SOLUTION |
MEDPHARMA PHARMACEUTICAL & CHEMICAL INDUSTRIES | 2006 | 1995-09-22 | 3 years | 2018-10-15 | 2019-01-13 |
| Clindamycin Hydrochloride | DALACIN |
PFIZER | 1992 | 1969-10-16 | 3 Years | 2018-10-15 | 2019-01-13 |
| Methylphenidate | Ritalin |
NOVARTIS | 1980 | 1954-10-06 | annual | 2018-10-31 | 2019-01-09 |
| OBINUTUZUMAB | Gazyva |
ROCHE | 2016 | 2013-11-01 | 6 months | 2018-10-31 | 2019-01-09 |
| SEVELAMER CARBONATE | Renvela |
SANOFI PASTEUR | 2015 | 1998-10-30 | annual | 2018-10-30 | 2019-01-08 |
| SEVELAMER HYDROCHLORIDE | Renagel |
SANOFI PASTEUR | 2005 | 1998-10-30 | annual | 2018-10-30 | 2019-01-08 |
| Human coagulation factor VIII/human von Willebrand factor | Koate |
INSTITUTO GRIFOLS | 2010 | 1989-03-02 | 3 years | 2018-10-07 | 2019-01-05 |