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
SAXAGLIPTIN ONGLYZA AstraZeneca 3 years
Ibuprofen (indicated in ductus arteriosus) JAZOFEN Jazeera Pharmaceutical Industries (JPI) 3 years
Ibuprofen (indicated in ductus arteriosus) BALKAPROFEN APM 3 years
Ibuprofen NUFEN Hikma Pharmaceuticals PLC 3 years
Ribavirin ribavirin APM 3 years
Natalizumab Tysabri Algorithm annual
Idursulfase Elaprase Algorithm annual
Epirubicin EPIRUBICIN JAZEERA Jazeera Pharmaceutical Industries (JPI) 3 years
METHOTREXATE METHOTREXATE SANOFI PASTEUR 3 years
Oxytocin GYNOCIN Jazeera Pharmaceutical Industries (JPI) 3 years


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