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 |
|---|---|---|---|---|---|---|---|
| Bisoprolol / hydrochlorothiazide | SELECTA PLUS |
JAMJOOM PHARMACEUTICALS COMPANY | 2009 | 3 years | 2018-11-30 | 2019-03-01 | |
| Levetiracetam | LAVIE |
JAMJOOM PHARMACEUTICALS COMPANY | 2016 | 2000-09-29 | 3 years | 2018-11-30 | 2019-03-01 |
| Lamivudine (hiv infections), lamivudine / zidovudine | COMBIVIR F.C |
GLAXOSMITHKLINE (GSK) | 2002 | 1998-03-18 | 3 years | 2018-11-30 | 2019-02-28 |
| Levetiracetam | KEPPRA |
GLAXOSMITHKLINE (GSK) | 2003 | 2000-09-29 | 3 years | 2018-11-30 | 2019-02-28 |
| Levetiracetam | EPITAM |
Jazeera Pharmaceutical Industries (JPI) | 2016 | 2000-09-29 | 3 years | 2018-11-30 | 2019-02-28 |
| Ergotamine tartrate/ Caffeine | CAFERGOT |
AMDIPHARMA | 2013 | 3 years | 2018-11-30 | 2019-02-28 | |
| OROS Hydromorphone | JURNISTA |
JANSSEN-CILAG | 2015 | 2004-12-22 | 3 years | 2018-11-30 | 2019-02-28 |
| Bisoprolol / hydrochlorothiazide | CARDICOR PLUS |
Jazeera Pharmaceutical Industries (JPI) | 2013 | 3 years | 2018-11-30 | 2019-02-28 | |
| Atomoxetine | Strattera 10 |
Eli Lilly | 2008 | 2002-11-26 | 3 years | 2018-11-26 | 2019-02-26 |
| Atomoxetine | Strattera 18 |
Eli Lilly | 2008 | 2002-11-26 | 3 years | 2018-11-26 | 2019-02-26 |