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 |
---|---|---|---|---|---|---|---|
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 |