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
Teriflunomide	Aubagio	SANOFI PASTEUR	2016-01-01	2012-09-12	annual	2018-09-12	2018-11-21
Miconazole Nitrate 20mg / Hydrocortisone 10mg	DAKTARIN	JANSSEN-CILAG	1981-01-01	1971-08-15	3 years	2018-08-14	2018-11-12
Pembrolizumab	Keytruda	MERCK SHARP & DOHME	2017-01-01	1997-08-25	6 months	2018-09-03	2018-11-12
Zoledronic acid	Aclasta Solution for infusion	NOVARTIS	2006-01-01	2005-09-15	3 years	2018-08-31	2018-11-09
Finasteride	PROSCAR	MERCK SHARP & DOHME	2016-01-01	1998-04-17	annual	2018-08-31	2018-11-09
Zoledronic acid	Zometa	NOVARTIS	2002-01-01	2000-08-21	annual	2018-08-31	2018-11-09
Finasteride	PROPECIA	MERCK SHARP & DOHME	2003-01-01	1998-04-17	annual	2018-08-31	2018-11-09
BROMAZEPAM	Lexotan	ROCHE	1980-01-01	2073-09-01	3 years	2018-08-31	2018-11-09
Enzalutamide	XTANDI	ASTELLAS PHARMA	2016-01-01	2012-08-31	annual	2018-08-30	2018-11-07
Maraviroc	CELSENTRI	GLAXOSMITHKLINE (GSK)	2010-01-01	2007-09-18	3 years	2018-08-05	2018-11-03

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