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 |
|---|---|---|---|---|---|---|---|
| Ibrutinib | IMBRUVICA |
JANSSEN-CILAG | 2015 | 2013-11-13 | Annual | 2017-11-12 | 2018-02-10 |
| Bacillus clausii | Enterogermina |
SANOFI PASTEUR | 2015 | 1978-11-03 | annual | 2017-11-30 | 2018-02-08 |
| Aflibercept | Eylea |
BAYER PHARMA AG | 2015 | 2011-11-18 | annual | 2017-11-30 | 2018-02-08 |
| Rotavirus vaccine, live, oral, pentavalen | ROTATEQ |
MERCK SHARP & DOHME | 2009 | 2006-06-27 | annual | 2017-11-27 | 2018-02-05 |
| SAXAGLIPTIN, METFORMIN HYDROCHLORIDE | KOMBIGLYZE XR |
AstraZeneca | 2013 | 2010-11-24 | annual | 2017-11-23 | 2018-02-01 |
| Hydroxyzine | ATARAX |
GLAXOSMITHKLINE (GSK) | 1983 | 18 months | 2017-11-01 | 2018-01-30 | |
| Simeprevir | OLYSIO |
JANSSEN-CILAG | 2014 | 2013-09-27 | Annual | 2017-11-21 | 2018-01-30 |
| Ketotifen (oral formulations) | TOTINAL |
Hikma Pharmaceuticals PLC | 1995 | 3 years | 2017-10-31 | 2018-01-29 | |
| MINOXIDIL | HAIRGAIN 2% W-V SOLUTION FOR WOMEN |
MEDPHARMA PHARMACEUTICAL & CHEMICAL INDUSTRIES | 2010 | 2007-03-19 | 2 years | 2017-10-31 | 2018-01-29 |
| MINOXIDIL | HAIRGAIN 5% W-V SOLUTION FOR MEN |
MEDPHARMA PHARMACEUTICAL & CHEMICAL INDUSTRIES | 2010 | 2007-03-19 | 2 years | 2017-10-31 | 2018-01-29 |