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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
Ibrutinib IMBRUVICA JANSSEN-CILAG Annual
Aflibercept Eylea BAYER PHARMA AG annual
Bacillus clausii Enterogermina SANOFI PASTEUR annual
Rotavirus vaccine, live, oral, pentavalen ROTATEQ MERCK SHARP & DOHME annual
SAXAGLIPTIN, METFORMIN HYDROCHLORIDE KOMBIGLYZE XR AstraZeneca annual
Hydroxyzine ATARAX GLAXOSMITHKLINE (GSK) 18 months
Simeprevir OLYSIO JANSSEN-CILAG Annual
Ketotifen (oral formulations) TOTINAL Hikma Pharmaceuticals PLC 3 years
MINOXIDIL HAIRGAIN 2% W-V SOLUTION FOR WOMEN MEDPHARMA PHARMACEUTICAL & CHEMICAL INDUSTRIES 2 years
MINOXIDIL HAIRGAIN 5% W-V SOLUTION FOR MEN MEDPHARMA PHARMACEUTICAL & CHEMICAL INDUSTRIES 2 years