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 |
|---|---|---|---|---|---|---|---|
| Dolutegravir | TIVICAY |
GLAXOSMITHKLINE (GSK) | 2014 | 2014-01-16 | 6 months | 2016-07-16 | 2017-03-27 |
| Allopurinol | PURINOL |
Hikma Pharmaceuticals PLC | 1985 | 1966-01-01 | annual | 2016-12-31 | 2017-03-11 |
| Dienogest | Visanne |
BAYER PHARMA AG | 2013 | 2009-12-10 | 3 years | 2016-12-02 | 2017-03-02 |
| Pneumococcal polysaccharide conjugate vaccine (adsorbed) - 10 valent | SYNFLORIX |
GLAXOSMITHKLINE (GSK) | 2010 | 2009-03-30 | annual | 2016-12-10 | 2017-02-18 |
| Calcium salts / colecalciferol | calcium salts / colecalciferol |
GLAXOSMITHKLINE (GSK) | 2011 | 3 years | 2016-10-31 | 2017-01-29 | |
| Human papillomavirus vaccine (rdna) - 2-valent | CERVARIX VACCINE |
GLAXOSMITHKLINE (GSK) | 2008 | 2007-09-20 | annual | 2016-11-17 | 2017-01-26 |
| Umeclidinium bromide | INCRUSE ELLIPTA |
GLAXOSMITHKLINE (GSK) | 2016 | 2014-04-16 | annual | 2016-10-15 | 2016-12-24 |
| Ropinirole | REQUIP |
GLAXOSMITHKLINE (GSK) | 2016 | 1996-07-08 | 3 years | 2016-07-08 | 2016-10-06 |
| Umeclidinium bromide / vilanterol | ANORO ELLIPTA |
GLAXOSMITHKLINE (GSK) | 2015 | 2013-12-18 | 6 months | 2016-06-17 | 2016-08-26 |
| IFENPRODIL TARTRATE | VADILEX |
SANOFI PASTEUR | 1983 | 1974-03-06 | 3 years | 2018-03-31 |