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 |
|---|---|---|---|---|---|---|---|
| Rifampicin/Isoniazid | Rifinah |
SANOFI PASTEUR | 1987 | 1968-05-01 | 3 years | 2019-05-01 | 2019-07-30 |
| Bemiparin | HIBOR |
Hikma Pharmaceuticals PLC | 2011 | 1998-04-16 | 3 years | 2019-04-30 | 2019-07-29 |
| Ethinylestradiol-Levonorgestrel | Logynon |
BAYER PHARMA AG | 1989 | 1976-02-20 | 3 years | 2019-04-13 | 2019-07-12 |
| RIFAMPICIN | RIMACTAZID 300MG TAB. |
SANDOZ | 2000 | 1969-01-30 | 3 Years | 2019-05-01 | 2019-07-10 |
| Retapamulin | ALTARGO |
GLAXOSMITHKLINE (GSK) | 2011 | 2007-05-24 | 3 years | 2019-04-11 | 2019-07-10 |
| BRINZOLAMIDE, TIMOLOL MALEATE | AZARGA EYE DROPS |
ALCON | 2011 | 2008-11-25 | 3 Years | 2019-04-30 | 2019-07-09 |
| Golimumab | SIMPONI |
JANSSEN-CILAG | 2015 | 2009-04-07 | 3 years | 2019-04-07 | 2019-07-06 |
| PRAMIPEXOLE | Sifrol |
BOEHRINGER INGELHEIM | 2000 | 1997-10-14 | 3 years | 2019-04-06 | 2019-07-05 |
| Tacrolimus monohydrate | PROTOPIC 0.03% OINTMENT |
ASTELLAS PHARMA | 2007 | 1993-04-02 | 3 years | 2019-03-31 | 2019-06-30 |
| Olanzapine | PRANZA |
Jazeera Pharmaceutical Industries (JPI) | 2016 | 1996-09-27 | 3 years | 2019-03-31 | 2019-06-29 |