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An official government website affiliated with the Government of the Kingdom of Saudi Arabia.
icon Wed 1 Jul 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
Diclofenac sodium Voltaren Gastro-resistant tablet NOVARTIS 3 years
Eltrombopag Revolade NOVARTIS annual
Baclofen Lioresal NOVARTIS 2 years
Diclofenac sodium Voltaren Suppository NOVARTIS 3 years
Hydrochlorothiazide Rasilez HCT NOVARTIS annual
Indacaterol Maleate Ultibro Breezhaler NOVARTIS annual
OCRELIZUMAB Ocrevus ROCHE 6 months
Denosumab Prolia AMGEN Annual
Denosumab Xgeva AMGEN Annual
Measles / mumps / rubella / varicella vaccines (live) PRIORIX-TETRA GLAXOSMITHKLINE (GSK) 3 years