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
Irbesartan	APROVEL	SANOFI PASTEUR	2002-01-01	1997-08-12	3 years	2018-09-30	2018-12-29
Irbesartan/HCTZ	CoAprovel	SANOFI PASTEUR	2009-01-01	1997-09-30	3 years	2018-09-30	2018-12-29
Insulin aspart	NovoMix 70 Penfill	NOVO NORDISK	2014-01-01	1999-09-30	3 years	2018-09-30	2018-12-29
Diclofenac (topical formulations)	diclofenac	GLAXOSMITHKLINE (GSK)	1992-01-01	1977-11-05	3 years	2018-09-30	2018-12-29
Diclofenac Sodium	VOTREX	Hikma Pharmaceuticals PLC	1996-01-01	1977-11-05	3 years	2018-09-30	2018-12-29
Diclofenac sodium	Emifenac 50 DT	SANOFI PASTEUR	1905-01-01	1984-10-31	3 years	2018-09-30	2018-12-29
Insulin aspart	NovoRapid FlexPen	NOVO NORDISK	2004-01-01	1999-09-30	3 years	2018-09-30	2018-12-29
Insulin aspart	NovoMix 50 FlexPen	NOVO NORDISK	2014-01-01	1999-09-30	3 years	2018-09-30	2018-12-29
diclofenac (systemic formulations,injection)	VOTREX	Hikma Pharmaceuticals PLC	1993-01-01	1977-11-05	3 years	2018-09-30	2018-12-29
Insulin aspart	NovoRapid Penfill	NOVO NORDISK	2004-01-01	1999-09-30	3 years	2018-09-30	2018-12-29

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