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 |
|---|---|---|---|---|---|---|---|
| Lapatinib | Tyverb |
NOVARTIS | 2013 | 2007-03-13 | annual | 2018-03-12 | 2018-05-21 |
| CILAZAPRIL AND CILAZAPRIL + HYDROCHLOROTHIAZOLE | Inhibace and inhibace plus |
ROCHE | 1997 | 2090-02-21 | 3 years | 2018-02-20 | 2018-05-21 |
| Amlodipine | Glodip |
SANOFI PASTEUR | 2012 | annual | 2018-03-07 | 2018-05-16 | |
| EPOETIN BETA | Neorecormon |
ROCHE | 2008 | 2090-02-14 | 3 years | 2018-02-13 | 2018-05-14 |
| TRAVOPROST | TRAVATAN EYE DROP |
ALCON | 2003 | 2001-03-16 | annual | 2018-02-28 | 2018-05-10 |
| CYCLOPENTOLATE | CYCLOGYL EYE DROPS 1% |
ALCON | 1992 | 1957-02-19 | annual | 2018-02-28 | 2018-05-10 |
| TRAVOPROST, TIMOLOL | DUOTRAV EYE DROPS |
ALCON | 2009 | 2002-02-12 | annual | 2018-02-28 | 2018-05-10 |
| Nepafenac | Nevanac |
ALCON | 2017 | 2005-08-19 | annual | 2018-05-30 | 2018-05-10 |
| AMPICILLIN | STANDACILLIN |
SANDOZ | 1988 | 1970-01-01 | 3 Years | 2018-02-28 | 2018-05-09 |
| Metformin/Vildagliptin | Eucreas |
NOVARTIS | 2010 | 2007-11-14 | 3 years | 2018-02-28 | 2018-05-09 |