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 |
|---|---|---|---|---|---|---|---|
| IPRATROPIUM BROMIDE | Atrovent |
BOEHRINGER INGELHEIM | 1987 | 1974-08-14 | 3 years | 2020-01-31 | 2020-04-30 |
| Omega-3-acid Ethyl Esters | OMACOR |
ABBOTT Laboratories | 2008 | 2000-12-07 | 3 years | 2020-01-22 | 2020-04-21 |
| Fampridine | Fampyra |
Algorithm | 2014 | 2011-07-20 | 3 years | 2020-01-21 | 2020-04-20 |
| Amisulpride | SOLIAN |
SANOFI PASTEUR | 2005 | 1986-01-20 | 3 years | 2020-01-20 | 2020-04-19 |
| Meningococcal Conjugate vaccine | Menactra |
SANOFI PASTEUR | 2011 | 2005-01-14 | 3 years | 2020-01-13 | 2020-04-12 |
| Pneumococcal Polysacchride Conjugate Vaccine, 13 Valent | PREVENAR 13 |
PFIZER | 2010 | 2009-07-10 | 3 years | 2020-01-09 | 2020-04-10 |
| Adalimumab | HUMIRA |
ABBVIE | 2006 | 2002-12-31 | 3 years | 2020-12-31 | 2020-03-30 |
| Repaglinide | NovoNorm 0.5mg |
NOVO NORDISK | 2001 | 1997-12-31 | 3 years | 2019-12-31 | 2020-03-30 |
| Repaglinide | NovoNorm 1mg |
NOVO NORDISK | 2001 | 1997-12-31 | 3 years | 2019-12-31 | 2020-03-30 |
| Repaglinide | NovoNorm 2mg |
NOVO NORDISK | 2001 | 1997-12-31 | 3 years | 2019-12-31 | 2020-03-30 |