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
Betahistine BETASERC ABBOTT Laboratories 3 years
Pseudoephedrine / triprolidine RINOFED Jazeera Pharmaceutical Industries (JPI) 3 years
Pseudoephedrine / triprolidine TRIFED Hikma Pharmaceuticals PLC 3 years
Betahistine BERTIGO Jazeera Pharmaceutical Industries (JPI) 3 years
Pseudoephedrine / triprolidine COLFED APM 3 years
Azelastine hydrochloride Allergodil MEDA PHARMA GmbH & Co KG 3 years
Celecoxib CELEBREX PFIZER 3 Years
Ombitasvir/Paritaprevir/ritonavir VIEKIRAX ABBVIE annual
Dasabuvir EXVIERA ABBVIE annual
Levonorgestrel Microlut 0.03 Mg BAYER PHARMA AG 3 years


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