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
Diclofenac sodium	Voltaren Gastro-resistant tablet	NOVARTIS	1980-01-01	1973-09-08	3 years	2018-09-30	2018-12-09
DICLOFENAC SODIUM	DICLAC	SANDOZ	2010-01-01	1984-12-03	3 Years	2018-09-30	2018-12-09
Diclofenac sodium	Voltaren Modified-release tablet	NOVARTIS	1982-01-01	1973-09-08	3 years	2018-09-30	2018-12-09
Diclofenac sodium	Voltaren Ophtha CD Eye drops	NOVARTIS	2002-01-01	1973-09-08	3 years	2018-09-30	2018-12-09
Diclofenac sodium	Voltaren Solution for injection	NOVARTIS	1980-01-01	1973-09-08	3 years	2018-09-30	2018-12-09
Indacaterol Maleate	Ultibro Breezhaler	NOVARTIS	2015-01-01	2013-09-19	annual	2018-09-28	2018-12-07
OCRELIZUMAB	Ocrevus	ROCHE	2018-01-01	2017-03-28	6 months	2018-09-27	2018-12-06
Denosumab	Xgeva	AMGEN	2014-01-01	2010-11-18	Annual	2018-09-26	2018-12-05
Denosumab	Prolia	AMGEN	2013-01-01	2010-05-26	Annual	2018-09-26	2018-12-05
Measles / mumps / rubella / varicella vaccines (live)	PRIORIX-TETRA	GLAXOSMITHKLINE (GSK)	2009-01-01	2006-07-26	3 years	2018-09-05	2018-12-04

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