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 |
|---|---|---|---|---|---|---|---|
| TELMISARTAN, AMLODIPINE | Twynsta |
BOEHRINGER INGELHEIM | 2014 | 2015-07-29 | 3 years | 2018-07-29 | 2018-10-27 |
| VEMURAFENIB | Zelboraf |
ROCHE | 2015 | 2011-08-17 | Annual | 2018-08-16 | 2018-10-25 |
| Tiapride | Tiapridal |
SANOFI PASTEUR | 1983 | 1988-07-27 | 3 years | 2018-07-27 | 2018-10-25 |
| Interferon beta-1b | Betaferon |
BAYER PHARMA AG | 2003 | 1993-07-23 | 3 years | 2018-07-23 | 2018-10-21 |
| Alprostadil | Prostin |
PFIZER | 1993 | 1981-07-23 | 3 Years | 2018-07-22 | 2018-10-20 |
| Nonacog Alfa | Nonacog Alfa |
PFIZER | 2012 | 1997-02-11 | annual | 2017-08-10 | 2018-10-19 |
| Palbociclib | IBRANCE |
PFIZER | 2016 | 2015-02-03 | 6 Months | 2017-05-08 | 2018-10-11 |
| NAPHAZOLINE HYDROCHLORIDE | NAPHCON FORTE 0.1% EYE DROPS |
ALCON | 1994 | 1973-06-01 | annual | 2018-07-31 | 2018-10-10 |
| NAPHAZOLINE HYDROCHLORIDE, PHENIRAMINE MALEATE | NAPHCON-A EYE DROPS |
ALCON | 1994 | 1977-06-01 | annual | 2018-07-31 | 2018-10-10 |
| METFORMIN HEXAL | METFORMIN HEXAL |
SANDOZ | 2010 | 1998-01-26 | 2 Years | 2018-07-31 | 2018-10-09 |