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 |
|---|---|---|---|---|---|---|---|
| TELITHROMYCIN | KETEK |
SANOFI PASTEUR | 2004 | 2001-07-09 | 3 years | 2018-07-09 | 2018-10-07 |
| DARIFENACIN HYDROBROMIDE | ENABLEX |
ASPEN | 2007 | 2004-10-22 | 3 years | 2015-10-31 | 2018-10-03 |
| RIBAVIRIN | Copegus |
ROCHE | 2016 | 1999-05-07 | 3 years | 2018-07-24 | 2018-10-02 |
| EXCHLORPHENIRAMINE MALEATE (+) PSEUDOEPHEDRINE SULFATE (+) GUAIFENESI | POLARAMINE |
MERCK SHARP & DOHME | 1984 | 3 years | 2018-06-30 | 2018-09-28 | |
| Carbimazol | NEO-MERCAZOLE |
AMDIPHARMA | 2011 | 1972-12-04 | 3 years | 2018-06-30 | 2018-09-28 |
| Carfilzomib | Kyprolis |
AMGEN | 2017 | 2012-07-20 | 6 months | 2018-06-19 | 2018-09-27 |
| Grazoprevir / elbasvir | Zepatier |
MERCK SHARP & DOHME | 2016 | 2016-01-19 | 6 Months | 2018-07-18 | 2018-09-26 |
| Peginterferon beta-1a | Plegridy |
Algorithm | 2016 | 2014-07-18 | annual | 2018-07-18 | 2018-09-26 |
| Ibuprofen ,Pseudoephedrine | ADVIL |
PFIZER | 2001 | 1989-09-18 | annual | 2017-07-18 | 2018-09-26 |
| Evolocumab | Repatha |
AMGEN | 2017 | 2015-07-17 | 6 months | 2018-07-17 | 2018-09-25 |