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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
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
Mixture of dissolved insulin
and isophane (NPH) insulin.
Mixtard 50 Penfill NOVO NORDISK 3 years
Suspension of
isophane (NPH) insulin.
Insulatard vial NOVO NORDISK 3 years
Varicella vaccine (live) VARILRIX GLAXOSMITHKLINE (GSK) 3 years
Tadalafile Cialis Eli Lilly 3 years
Tadalafile Cialis Once Daily Eli Lilly 3 years
Levodopa + Carbidopa DUODOPA intestinal gel ABBVIE 3 years
Insulin degludec/insulin aspart Ryzodeg Penfill 100 IU/ml NOVO NORDISK 3 years
Insulin degludec Tresiba FlexTouch 200 NOVO NORDISK 3 years
Insulin degludec Tresiba Penfill 100 NOVO NORDISK 3 years
Insulin degludec Tresiba FlexTouch 100 NOVO NORDISK 3 years