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 |
|---|---|---|---|---|---|---|---|
| Memantine | MEMAXIA |
JAMJOOM PHARMACEUTICALS COMPANY | 2007 | 2002-05-15 | 3 years | 2018-09-15 | 2018-12-14 |
| Filgrastim | Neupogen |
AMGEN | 2002 | 1991-02-20 | 3 years | 2018-09-15 | 2018-12-14 |
| Alfentanil Hydrochloride | RAPIFEN |
JANSSEN-CILAG | 1992 | 1982-12-01 | 3 years | 2018-09-14 | 2018-12-13 |
| Teriparatide (PTH ) | Forteo |
Eli Lilly | 2006 | 2002-11-26 | 3 years | 2018-09-12 | 2018-12-11 |
| Hydrochlorothiazide | Rasilez HCT |
NOVARTIS | 2011 | 2008-01-18 | annual | 2018-09-30 | 2018-12-09 |
| Eltrombopag | Revolade |
NOVARTIS | 2012 | 2008-11-20 | annual | 2018-09-30 | 2018-12-09 |
| Diclofenac sodium | Voltaren Gastro-resistant tablet |
NOVARTIS | 1980 | 1973-09-08 | 3 years | 2018-09-30 | 2018-12-09 |
| Diclofenac sodium | Voltaren Modified-release tablet |
NOVARTIS | 1982 | 1973-09-08 | 3 years | 2018-09-30 | 2018-12-09 |
| Diclofenac sodium | Voltaren Ophtha CD Eye drops |
NOVARTIS | 2002 | 1973-09-08 | 3 years | 2018-09-30 | 2018-12-09 |
| Diclofenac sodium | Voltaren Solution for injection |
NOVARTIS | 1980 | 1973-09-08 | 3 years | 2018-09-30 | 2018-12-09 |