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
Etanercept	ENBREL	PFIZER	2007-01-01	1998-11-02	annual	2018-02-02	2018-04-13
Gemcitabine	Gemzar 200 mg	Eli Lilly	1999-01-01	1995-01-12	3 years	2018-01-12	2018-04-12
Pregabalin	LYRICA	PFIZER	2006-01-01	2004-07-06	annual	2018-01-31	2018-04-11
Nilotinib hydrochloride monohydrate	Tasigna Capsule 200 mg	NOVARTIS	2008-01-01	2007-07-24	annual	2018-01-31	2018-04-11
DEXAMETHASONE, HYPROMELLOSE	MAXIDEX DROPS 0.1%	ALCON	1982-01-01	1952-01-01	annual	2018-01-31	2018-04-10
NEOMYCIN SULPHATE, POLYMYXIN B SULPHATE, DEXAMETHASONE	MAXITROL EYE OINT.	ALCON	1994-01-01	1952-01-01	annual	2018-01-31	2018-04-10
NEOMYCIN SULPHATE, POLYMYXIN B SULPHATE, DEXAMETHASONE	MAXITROL DROPS	ALCON	1981-01-01	1952-01-01	annual	2018-01-31	2018-04-10
Axitinib	INLYTA	PFIZER	2015-01-01	2012-01-27	annual	2018-01-26	2018-04-06
CALCITRIOL	Rocaltrol	ROCHE	1980-01-01	2078-01-01	3 years	2018-01-01	2018-04-01
Tetanus vaccine	Tetavax	SANOFI PASTEUR	2007-01-01	1987-07-25	3 years	2018-01-01	2018-04-01

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