Periodic safety reporting schedule

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Active Substances Trade Name MAH Year of registration in Saudi Arabia International Birth Date (IBD) PSUR Submission Frequency Data Lock Point (DLP) Submission Date
Cinacalcet Mimpara AMGEN 3 years
Desvenlafaxine Succinate PRISTIQ PFIZER 3 Years
Rocuronium RUCORON Jazeera Pharmaceutical Industries (JPI) 3 years
Zinc chloride, Copper chloride dihydrate, Manganese chloride tetrahydrate,
Sodium selenite pentahydrate, Sodium fluoride, Potassium iodide
Peditrace FRESENIUS KABI 3 years
Degarelix Firmagon FERRING 3 years
Dorzolamide / timolol XOLAMOL JAMJOOM PHARMACEUTICALS COMPANY 3 years
Dorzolamide XOLA JAMJOOM PHARMACEUTICALS COMPANY 3 years
Pimozide ORAP FORTE JANSSEN-CILAG 3 years
Acetylsalicylic Acid Aspirin Protect 100Mg BAYER PHARMA AG 3 years
Acetylsalicylic Acid Aspirin Adult 300Mg BAYER PHARMA AG 3 years


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