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 |
|---|---|---|---|---|---|---|---|
| Afatinib | Giotrif |
BOEHRINGER INGELHEIM | 2014 | 2013-09-25 | annual | 2018-09-25 | 2018-12-04 |
| Etonogestrel implant- implanon | IMPLANON NXT |
MERCK SHARP & DOHME | 2004 | 1998-08-28 | 3 years | 2018-09-01 | 2018-11-30 |
| Lacosamide | Vimpat |
U.C.B | 2016 | 2008-08-29 | 3 years | 2018-08-31 | 2018-11-30 |
| Meropenem | MEPRA |
Jazeera Pharmaceutical Industries (JPI) | 2015 | 3 years | 2018-08-31 | 2018-11-29 | |
| Ceftolozane / Tazobactam | Zerbaxa |
MERCK SHARP & DOHME | 2017 | 2015-09-18 | 6 months | 2018-09-18 | 2018-11-27 |
| Dabigatran | PRADAXA |
BOEHRINGER INGELHEIM | 2009 | 2008-03-18 | annual | 2018-09-18 | 2018-11-27 |
| Moroctocog Alfa | XYNTHA |
PFIZER | 2012 | 1999-04-13 | 2 Years | 2018-08-26 | 2018-11-24 |
| ACETYLCYSTEINE | ACC 200MG POWDER FOR ORAL SOLUTION |
SANDOZ | 2009 | 1985-12-05 | 3 Years | 2018-09-13 | 2018-11-22 |
| ACETYLCYSTEINE | ACC LONG 600MG EFFERVESCENT TABLETS |
SANDOZ | 2009 | 1985-12-05 | 3 Years | 2018-09-13 | 2018-11-22 |
| Granisetron | SANCUSO 34.3 mg transdermal patch |
ProStrakan Inc | 2014 | 2008-09-12 | annual | 2018-09-11 | 2018-11-21 |