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 |
|---|---|---|---|---|---|---|---|
| Diclofenac sodium | Voltaren Suppository |
NOVARTIS | 1980 | 1973-09-08 | 3 years | 2018-09-30 | 2018-12-09 |
| Diclofenac potassium | Voltfast Powder for oral solution |
NOVARTIS | 2007 | 1984-05-11 | 3 years | 2018-09-30 | 2018-12-09 |
| DICLOFENAC SODIUM | DICLAC |
SANDOZ | 2010 | 1984-12-03 | 3 Years | 2018-09-30 | 2018-12-09 |
| Diclofenac potassium | Cataflam |
NOVARTIS | 2007 | 1984-05-11 | 3 years | 2018-09-30 | 2018-12-09 |
| Baclofen | Lioresal |
NOVARTIS | 1987 | 1970-09-17 | 2 years | 2018-09-30 | 2018-12-09 |
| Indacaterol Maleate | Ultibro Breezhaler |
NOVARTIS | 2015 | 2013-09-19 | annual | 2018-09-28 | 2018-12-07 |
| OCRELIZUMAB | Ocrevus |
ROCHE | 2018 | 2017-03-28 | 6 months | 2018-09-27 | 2018-12-06 |
| Denosumab | Prolia |
AMGEN | 2013 | 2010-05-26 | Annual | 2018-09-26 | 2018-12-05 |
| Denosumab | Xgeva |
AMGEN | 2014 | 2010-11-18 | Annual | 2018-09-26 | 2018-12-05 |
| Measles / mumps / rubella / varicella vaccines (live) | PRIORIX-TETRA |
GLAXOSMITHKLINE (GSK) | 2009 | 2006-07-26 | 3 years | 2018-09-05 | 2018-12-04 |