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
Iloprost	Ventavis	BAYER PHARMA AG	2016-01-01	2003-09-16	3 years	2017-09-15	2017-12-14
Dapagliflozin	FORXIGA	AstraZeneca	2016-01-01	2012-10-05	annual	2017-10-04	2017-12-13
Panitumumab	Vectibix	AMGEN	2013-01-01	2006-09-27	Annual	2017-09-30	2017-12-09
Eltrombopag olamine	Eltrombopag Olamine	GLAXOSMITHKLINE (GSK)	2012-01-01	2010-03-11	annual	2017-09-30	2017-12-09
Fluxetine	Prozac	Eli Lilly	2008-01-01	1986-09-07	3 years	2017-08-07	2017-12-06
Regorafenib	Stivarga	BAYER PHARMA AG	2014-01-01	2012-09-27	annual	2017-09-26	2017-12-05
Estradiol hemihydrate	Vagifem 25 mcg	NOVO NORDISK	2017-01-01	2010-08-31	3 years	2017-08-31	2017-11-29
Suxamethonium	MIDARINE	GLAXOSMITHKLINE (GSK)	2004-01-01		3 years	2017-08-31	2017-11-29
Estradiol hemihydrate	Vagifem 25 mcg	NOVO NORDISK	1998-01-01	2010-08-31	3 years	2017-08-31	2017-11-29
Riociguat	Adempas	BAYER PHARMA AG	2015-01-01	2013-09-19	annual	2017-09-19	2017-11-28

Share page