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
Aclidinium bromide EKLIRA GENUAIR AstraZeneca annual
Cilastatin / imipenem ZAYNAM Jazeera Pharmaceutical Industries (JPI) 3 years
Aripiprazole ARIPO Jazeera Pharmaceutical Industries (JPI) annual
Pitavastatin Livazo Algorithm annual
Rotavirus vaccine monovalent (live, oral) ROTARIX GLAXOSMITHKLINE (GSK) annual
Tedizolid phosphate Sivextro BAYER PHARMA AG 1 year
Cyproterone acetate-Ethinylestradiol Diane-35 BAYER PHARMA AG 3 years
Tramadol TRAMADONE APM 3 years
Human fibrinogen / human thrombin TACHOSIL Jazeera Pharmaceutical Industries (JPI) 6 months
Azithromycin (systemic use ) ZEROX Hikma Pharmaceuticals PLC 3 years


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