icon
An official government website affiliated with the Government of the Kingdom of Saudi Arabia.
icon Mon 17 Aug 2026
Beta version
icon
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.

icon
Official Reliable websites use HTTPS

Ensure the website is using the HTTPS protocol.

icon

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
Granisetron SANCUSO 34.3 mg transdermal patch ProStrakan Inc annual
Pembrolizumab Keytruda MERCK SHARP & DOHME 6 months
Miconazole Nitrate 20mg / Hydrocortisone 10mg DAKTARIN JANSSEN-CILAG 3 years
Finasteride PROPECIA MERCK SHARP & DOHME annual
Finasteride PROSCAR MERCK SHARP & DOHME annual
BROMAZEPAM Lexotan ROCHE 3 years
Zoledronic acid Aclasta Solution for infusion NOVARTIS 3 years
Zoledronic acid Zometa NOVARTIS annual
Enzalutamide XTANDI ASTELLAS PHARMA annual
Maraviroc CELSENTRI GLAXOSMITHKLINE (GSK) 3 years