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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
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
Measles / mumps / rubella / varicella vaccines (live) PRIORIX-TETRA GLAXOSMITHKLINE (GSK) 3 years
Lacosamide Vimpat U.C.B 3 years
Etonogestrel implant- implanon IMPLANON NXT MERCK SHARP & DOHME 3 years
Meropenem MEPRA Jazeera Pharmaceutical Industries (JPI) 3 years
Dabigatran PRADAXA BOEHRINGER INGELHEIM annual
Ceftolozane / Tazobactam Zerbaxa MERCK SHARP & DOHME 6 months
Moroctocog Alfa XYNTHA PFIZER 2 Years
ACETYLCYSTEINE ACC LONG 600MG EFFERVESCENT TABLETS SANDOZ 3 Years
ACETYLCYSTEINE ACC 200MG POWDER FOR ORAL SOLUTION SANDOZ 3 Years
Granisetron SANCUSO 34.3 mg transdermal patch ProStrakan Inc annual