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An official government website affiliated with the Government of the Kingdom of Saudi Arabia.
icon Sun 16 Aug 2026
Beta version
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Official Saudi government website domains end with gov.sa

All official websites of government entities in the Kingdom of Saudi Arabia end with.gov.sa.

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Official Reliable websites use HTTPS

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Registered with the Digital Government Authority under number:

20250831619
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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
Epirubicin EPIRUBICIN JAZEERA Jazeera Pharmaceutical Industries (JPI) 3 years
Cilastatin / imipenem ZAYNAM Jazeera Pharmaceutical Industries (JPI) 3 years
Pitavastatin Livazo Algorithm annual
Aripiprazole ARIPO Jazeera Pharmaceutical Industries (JPI) annual
Rotavirus vaccine monovalent (live, oral) ROTARIX GLAXOSMITHKLINE (GSK) annual
Cyproterone acetate-Ethinylestradiol Diane-35 BAYER PHARMA AG 3 years
Tedizolid phosphate Sivextro BAYER PHARMA AG 1 year
Tramadol TRAMADONE APM 3 years
Human fibrinogen / human thrombin TACHOSIL Jazeera Pharmaceutical Industries (JPI) 6 months
Valsartan DIOSTAR Pharma International Co 3 years