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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
Ketotifen Gloditen 1mg tablets
Gloditen 1mg/5ml
SANOFI PASTEUR 3 years
Darbepoetin Alfa Aranesp AMGEN 3 years
Human Insulin Humulin R Cartrides Eli Lilly 3 years
Human Insulin Humulin N Cartridges Eli Lilly 3 years
Human Insulin Humulin N 100 Iuml/ml 10 ml Eli Lilly 3 years
Human Insulin Humulin R 100 IU/ml 10 ml Eli Lilly 3 years
Human Insulin Humulin 70/30 Cartridges Eli Lilly 3 years
Human Insulin Humulin 70/30 100 IU/ml 10 ml Eli Lilly 3 years
Daratumumab DARZALEX JANSSEN-CILAG 6 months
Diphtheria / tetanus / pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin) (acellular, component) / hepatitis b (rdna) / poliomyelitis (inactivated) / haemophilus type b conjugate vaccines (adsorbed) INFANRIX GLAXOSMITHKLINE (GSK) 3 years