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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
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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
Ondansetron ondansetron APM 3 years
Hepatitis b vaccine (recombinant) Recombivax HB MERCK SHARP & DOHME 2 years
Hepatitis b vaccine (rdna) ENGERIX GLAXOSMITHKLINE (GSK) 2 years
Ampicillin Sodium, Sulbactam Sodium UNASYN PFIZER 3 Years
Galantamine Hydrobromide REMINYL JANSSEN-CILAG 3 years
Ondansetron (Injection) DANSETRON Hikma Pharmaceuticals PLC 3 years
Influenza vaccine INFLUVAC ABBOTT Laboratories annual
Influenza vaccine Vaxigrip SANOFI PASTEUR annual
Dexmedetomidine Hydrochloride PRECEDEX PFIZER annual
Lapatinib Tyverb NOVARTIS annual