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 |
|---|---|---|---|---|---|---|---|
| Secukinumab | Cosentyx |
NOVARTIS | 2016 | 2014-12-26 | annual | 2017-12-25 | 2018-03-05 |
| Diphtheria, Tetanus & Pertussis vaccine | DT Coq |
SANOFI PASTEUR | 1998 | 1957-12-06 | 3 years | 2017-12-05 | 2018-03-04 |
| AMIODARONE | SEDACORON |
SANDOZ | 2002 | 1997-10-29 | 3 Years | 2017-12-20 | 2018-02-28 |
| Methylprednisolone | MEDROLONE |
Jazeera Pharmaceutical Industries (JPI) | 2016 | 3 years | 2017-11-30 | 2018-02-28 | |
| Methylprednisolone aceponate | Advantan |
BAYER PHARMA AG | 2004 | 1990-11-07 | 3 years | 2017-11-30 | 2018-02-28 |
| 5-FLUOROURACIL | FLUOROURACIL EBEWE AMP |
SANDOZ | 2007 | 2001-05-21 | 3 Years | 2017-12-16 | 2018-02-24 |
| Norelgestromin /Ethinyl Estradiol | EVRA |
JANSSEN-CILAG | 2006 | 2001-11-20 | 3 years | 2017-11-19 | 2018-02-17 |
| FONDAPARINUX | ARIXTRA |
ASPEN | 2004 | 2002-03-21 | annual | 2018-12-06 | 2018-02-14 |
| Venetoclax | VENCLEXTA |
ABBVIE | 2017 | 2016-04-11 | 6 months | 2019-12-04 | 2018-02-12 |
| Diphtheria, Tetanus Toxoids, Acellular Pertussis, Inactivated Poliomyelitis & Haemophilus b Conjugate Vaccine |
Pediacel |
SANOFI PASTEUR | 2008 | 2000-12-08 | 3 years | 2017-11-13 | 2018-02-11 |