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 |
|---|---|---|---|---|---|---|---|
| Glimepiride + Metformin HCL | Amaryl |
SANOFI PASTEUR | 2016 | 2005-05-19 | 3 year | 2018-05-19 | 2018-08-18 |
| PERTUZUMAB | Perjeta |
ROCHE | 2014 | 2012-06-08 | Annual | 2018-06-07 | 2018-08-16 |
| Azacitidine | Vidaza |
Algorithm | 2015 | 2008-12-17 | 3 years | 2018-05-18 | 2018-08-16 |
| MINERAL OIL, ANHYDROUS LIQUID LANOLIN, WHIT PETROLATUM | DURATEARS OCULAR OINT. |
ALCON | 1997 | 1976-12-01 | annual | 2018-05-31 | 2018-08-10 |
| MOXIFLOXACIN | VIGAMOX 0.5% OPHTHALMIC SOLUTION |
ALCON | 2005 | 2003-04-01 | annual | 2018-05-31 | 2018-08-10 |
| DEXTRAN 70, HYPROMELLOSE | TEARS NATURAL FREE |
ALCON | 2000 | 1976-04-01 | annual | 2018-05-31 | 2018-08-10 |
| DEXTRAN 70, HYPROMELLOSE | TEARS NATURALE |
ALCON | 1995 | 1976-04-01 | annual | 2018-05-31 | 2018-08-10 |
| DEXTRAN 70, HYPROMELLOSE | TEARS NATURALE II |
ALCON | 1997 | 1976-04-01 | annual | 2018-05-31 | 2018-08-10 |
| EMEDASTINE | EMADINE 0.05% EYE DROPS |
ALCON | 1999 | 1997-12-29 | 3 Years | 2018-05-31 | 2018-08-09 |
| Quadrivalent human papillomavirus (types 6,11,16,18) recomb.vacc | GARDASIL RECOMBINANT VACCINE |
MERCK SHARP & DOHME | 2008 | 2006-09-20 | annual | 2018-05-31 | 2018-08-09 |