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An official government website affiliated with the Government of the Kingdom of Saudi Arabia.
icon Mon 17 Aug 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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Official Reliable websites use HTTPS

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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
Insulin aspart NovoRapid Penfill NOVO NORDISK 3 years
Insulin aspart NovoRapid FlexPen NOVO NORDISK 3 years
Diclofenac (topical formulations) diclofenac GLAXOSMITHKLINE (GSK) 3 years
Insulin aspart NovoMix 70 Penfill NOVO NORDISK 3 years
Insulin aspart NovoMix 50 Penfill NOVO NORDISK 3 years
diclofenac (systemic formulations,injection) VOTREX Hikma Pharmaceuticals PLC 3 years
Insulin aspart NovoMix 70 FlexPen NOVO NORDISK 3 years
Irbesartan APROVEL SANOFI PASTEUR 3 years
Irbesartan/HCTZ CoAprovel SANOFI PASTEUR 3 years
Insulin aspart NovoMix 30 Penfill NOVO NORDISK 3 years