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
LINAGLIPTIN	Trajenta	BOEHRINGER INGELHEIM	2013-01-01	2011-08-24	3 years	2018-05-02	2018-07-31
Praziquantel	Biltricide	BAYER PHARMA AG	1984-01-01	1980-05-01	3 years	2018-04-30	2018-07-29
Fentanyl	DUROGESIC , FENTANYL-JANSSEN	JANSSEN-CILAG	1999-01-01	1994-03-31	3 years	2018-04-30	2018-07-29
Olopatadine	OLOPAT	JAMJOOM PHARMACEUTICALS COMPANY	2003-01-01		3 years	2018-04-30	2018-07-29
Terlipressin	Glypressin powder and solvent for solution for injection	FERRING	2007-01-01	1980-05-01	3 years	2018-04-30	2018-07-29
Terlipressin	Glypressin solution for injection	FERRING	2014-01-01	1980-05-01	3 years	2018-04-30	2018-07-29
Oxaliplatin	Eloxatin	SANOFI PASTEUR	2008-01-01	1996-04-12	3 years	2018-04-30	2018-07-29
CAPECITABINE	Xeloda	ROCHE	2004-01-01	2098-04-30	3 years	2018-04-29	2018-07-28
Abiraterone Acetate	ZYTIGA	JANSSEN-CILAG	2013-01-01	2011-04-28	3 years	2018-04-27	2018-07-26
Apixaban	ELIQUIS	PFIZER	2014-01-01	2011-05-18	annual	2017-05-17	2018-07-26

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