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 |
|---|---|---|---|---|---|---|---|
| Pazopanib | Votrient |
NOVARTIS | 2012 | 2009-10-19 | annual | 2018-10-18 | 2018-12-27 |
| Carbidopa/Entacapone/Levodopa | Stalevo |
NOVARTIS | 2006 | 2003-06-11 | 3 years | 2018-10-17 | 2018-12-26 |
| CEFTAZIDIME | PARZIDIME |
SANDOZ | 2010 | 2002-08-15 | 3 Years | 2018-10-17 | 2018-12-26 |
| Bromocriptine | Parlodel Tablet |
NOVARTIS | 1981 | 1975-05-05 | 3 years | 2018-10-15 | 2018-12-24 |
| Nintedanib | Ofev |
BOEHRINGER INGELHEIM | 2017 | 2014-10-15 | annual | 2018-10-15 | 2018-12-24 |
| Hepatitis a (inactivated) / hepatitis b (rdna) vaccines (adsorbed) | TWINRIX ADULT MONODOSE |
GLAXOSMITHKLINE (GSK) | 2000 | 1996-09-20 | 3 years | 2018-09-20 | 2018-12-19 |
| OSELTAMIVIR | Tamiflu |
ROCHE | 2017 | 2099-09-21 | 3 years | 2018-09-20 | 2018-12-19 |
| Oseltamivir | OSELTA |
JAMJOOM PHARMACEUTICALS COMPANY | 2001 | 2002-06-20 | 3 years | 2018-09-20 | 2018-12-19 |
| Adefovir | HEPSERA |
GLAXOSMITHKLINE (GSK) | 2005 | 2003-03-06 | 3 years | 2018-09-20 | 2018-12-19 |
| Memantine | DEMENT |
Jazeera Pharmaceutical Industries (JPI) | 2016 | 2002-05-15 | 3 years | 2018-09-15 | 2018-12-14 |