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 |
|---|---|---|---|---|---|---|---|
| Abiraterone Acetate | ZYTIGA |
JANSSEN-CILAG | 2013 | 2011-04-28 | 3 years | 2018-04-27 | 2018-07-26 |
| Fluticasone furoate | AVAMYS |
GLAXOSMITHKLINE (GSK) | 2009 | 2008-01-11 | 3 years | 2018-04-26 | 2018-07-25 |
| Bortezomib | VELCADE |
JANSSEN-CILAG | 2006 | 2003-05-13 | 3 years | 2018-04-26 | 2018-07-25 |
| Imatinib mesilate | Glivec |
NOVARTIS | 2005 | 2001-05-10 | 3 years | 2018-05-10 | 2018-07-19 |
| ISOTRETINOIN | Roaccutane |
ROCHE | 2015 | 2082-05-07 | Annual | 2018-05-06 | 2018-07-15 |
| Ofloxacin | OPTIFLOX |
JAMJOOM PHARMACEUTICALS COMPANY | 1994 | 1985-04-16 | 3 years | 2018-04-16 | 2018-07-15 |
| Ofloxacin 0.3% | Oflox Eye Drops |
Allergan | 1994 | 1985-04-16 | 3 Year | 2018-04-16 | 2018-07-15 |
| Ofloxacin | Tarivid |
SANOFI PASTEUR | 1996 | 1985-04-16 | 3years | 2018-04-16 | 2018-07-15 |
| Tofacitinib Citrate | XELJANZ |
PFIZER | 2015 | 2012-11-06 | 6 Months | 2017-05-05 | 2018-07-14 |
| Mycophenolic acid | Myfortic |
NOVARTIS | 2004 | 2002-10-24 | annual | 2018-05-02 | 2018-07-11 |