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
Ofatumumab	Arzerra	NOVARTIS	2013-01-01	2009-10-26	annual	2018-10-25	2019-01-03
Pasireotide	Signifor	NOVARTIS	2015-01-01	2012-04-29	annual	2018-10-24	2019-01-02
Metoclopramide	CLOPRAM	Jazeera Pharmaceutical Industries (JPI)	2016-01-01	1966-10-03	3 years	2018-10-03	2019-01-01
Metoclopramide	PRIMPERAN 10mg	SANOFI PASTEUR	1982-01-01	1964-11-17	3 years	2018-10-03	2019-01-01
Levofloxacin	LEVONIC	Jazeera Pharmaceutical Industries (JPI)	2012-01-01	1993-01-10	3 years	2018-10-01	2018-12-30
Levofloxacin	Tavanic	SANOFI PASTEUR	2003-01-01	1993-10-01	3 years	2018-10-01	2018-12-30
Levofloxacin	NEVOTIC	Pharma International Co	2017-01-01	1993-01-10	3 years	2018-10-01	2018-12-30
DICLOFENAC SODIUM	DICLON 1% EMULGEL	MEDPHARMA PHARMACEUTICAL & CHEMICAL INDUSTRIES	2006-01-01	1977-05-11	3 years	2018-09-30	2018-12-29
Insulin aspart	NovoMix 30 Penfill	NOVO NORDISK	2003-01-01	1999-09-30	3 years	2018-09-30	2018-12-29
Diclofenac (topical )	INFLA-BAN	APM	1994-01-01	1977-11-05	3 years	2018-09-30	2018-12-29

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