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 |
|---|---|---|---|---|---|---|---|
| MYCOPHENOLATE MOFETIL | Cellcept |
ROCHE | 2000 | 2095-05-03 | Annual | 2018-05-02 | 2018-07-11 |
| Methylprednisolone | DEPO MEDROL |
PFIZER | 1984 | 1957-09-10 | 3 Years | 2017-11-30 | 2018-07-11 |
FLUTICASONE PROPIONATE/FORMOTEROL FUMERATE |
FLUTIFORM |
NAPP PHARMACEUTICALS LIMITED | 2016 | 2015-04-01 | annual | 2016-07-31 | 2018-07-11 |
| PREDNISOLONE ACETATE | OMNIPRED |
ALCON | 2001 | 1971-04-01 | annual | 2018-04-30 | 2018-07-10 |
| POLYETHYLENE GLYCOL, PROPYLENE GLYCOL | SYSTANE LUBRICANT EYE DROPS |
ALCON | 2003 | 2003-01-01 | annual | 2018-04-30 | 2018-07-10 |
| Polyethylene Glycol | Systane Gel drops |
ALCON | 2015 | 2003-01-01 | annual | 2018-04-30 | 2018-07-10 |
| Polyethylene Glycol | Systane Ultra MD |
ALCON | 2015 | 2003-01-01 | annual | 2018-04-30 | 2018-07-10 |
| Polyethylene Glycol | Systane Ultra UD |
ALCON | 2015 | 2003-01-01 | annual | 2018-04-30 | 2018-07-10 |
| Polyethylene Glycol | Systane lid wipes |
ALCON | 2015 | 2003-01-01 | annual | 2018-04-30 | 2018-07-10 |
| OLOPATADINE | PATADAY 0.2% OPHTHALMIC SOLUTION |
ALCON | 2009 | 1996-12-01 | 3 Years | 2018-04-30 | 2018-07-09 |