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 |
|---|---|---|---|---|---|---|---|
| Teriflunomide | Aubagio |
SANOFI PASTEUR | 2016 | 2012-09-12 | annual | 2018-09-12 | 2018-11-21 |
| Pembrolizumab | Keytruda |
MERCK SHARP & DOHME | 2017 | 1997-08-25 | 6 months | 2018-09-03 | 2018-11-12 |
| Miconazole Nitrate 20mg / Hydrocortisone 10mg | DAKTARIN |
JANSSEN-CILAG | 1981 | 1971-08-15 | 3 years | 2018-08-14 | 2018-11-12 |
| Zoledronic acid | Zometa |
NOVARTIS | 2002 | 2000-08-21 | annual | 2018-08-31 | 2018-11-09 |
| BROMAZEPAM | Lexotan |
ROCHE | 1980 | 2073-09-01 | 3 years | 2018-08-31 | 2018-11-09 |
| Zoledronic acid | Aclasta Solution for infusion |
NOVARTIS | 2006 | 2005-09-15 | 3 years | 2018-08-31 | 2018-11-09 |
| Finasteride | PROPECIA |
MERCK SHARP & DOHME | 2003 | 1998-04-17 | annual | 2018-08-31 | 2018-11-09 |
| Finasteride | PROSCAR |
MERCK SHARP & DOHME | 2016 | 1998-04-17 | annual | 2018-08-31 | 2018-11-09 |
| Enzalutamide | XTANDI |
ASTELLAS PHARMA | 2016 | 2012-08-31 | annual | 2018-08-30 | 2018-11-07 |
| Maraviroc | CELSENTRI |
GLAXOSMITHKLINE (GSK) | 2010 | 2007-09-18 | 3 years | 2018-08-05 | 2018-11-03 |