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An official government website affiliated with the Government of the Kingdom of Saudi Arabia.
icon Thu 25 Jun 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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Government websites use the protocol. HTTPS for encryption and security.

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

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Registered with the Digital Government Authority under number:
20250831619
Suggestions

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
Azithromycin (systemic use ) ZEROX Hikma Pharmaceuticals PLC 3 years
Azithromycin azithromycin APM 3 years
Radium 223- Dichloride Xofigo BAYER PHARMA AG annual
Fluticasone furoate / vilanterol RELVAR GLAXOSMITHKLINE (GSK) annual
Isotretinoin (oral formulations) XERACTAN Jazeera Pharmaceutical Industries (JPI) annual
Isotretenoin Isotretenoin GLAXOSMITHKLINE (GSK) annual
Latanoprost / timolol LATANOCOM JAMJOOM PHARMACEUTICALS COMPANY 3 years
Simvastatin SIMCOR Pharma International Co 3 years
Simvastatin SIMVA JAMJOOM PHARMACEUTICALS COMPANY 3 years
Febuxostat Adenuric Algorithm annual