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
Ceftazidime	FORTA-Z	Jazeera Pharmaceutical Industries (JPI)	2016-01-01		3 years	2018-10-17	2019-01-15
Ceftazidime	FORTUM	GLAXOSMITHKLINE (GSK)	1987-01-01		3 years	2018-10-17	2019-01-15
CLINDAMYCIN PHOSPHATE	MEDACIN -T 1% TOPICAL SOLUTION	MEDPHARMA PHARMACEUTICAL & CHEMICAL INDUSTRIES	2006-01-01	1995-09-22	3 years	2018-10-15	2019-01-13
CLINDAMYCIN PHOSPHATE	MEDACIN -T 1% GEL	MEDPHARMA PHARMACEUTICAL & CHEMICAL INDUSTRIES	2008-01-01	1995-09-22	3 years	2018-10-15	2019-01-13
Clindamycin Hydrochloride	DALACIN	PFIZER	1992-01-01	1969-10-16	3 Years	2018-10-15	2019-01-13
OBINUTUZUMAB	Gazyva	ROCHE	2016-01-01	2013-11-01	6 months	2018-10-31	2019-01-09
Methylphenidate	Ritalin	NOVARTIS	1980-01-01	1954-10-06	annual	2018-10-31	2019-01-09
SEVELAMER HYDROCHLORIDE	Renagel	SANOFI PASTEUR	2005-01-01	1998-10-30	annual	2018-10-30	2019-01-08
SEVELAMER CARBONATE	Renvela	SANOFI PASTEUR	2015-01-01	1998-10-30	annual	2018-10-30	2019-01-08
Human coagulation factor VIII/human von Willebrand factor	Koate	INSTITUTO GRIFOLS	2010-01-01	1989-03-02	3 years	2018-10-07	2019-01-05

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