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
Fluconazole fluconazole APM 3 years
Fluconazole FLUCORAL Jazeera Pharmaceutical Industries (JPI) 3 years
Fuconazole (Injection) FLUCAND Hikma Pharmaceuticals PLC 3 years
IBUPROFEN MEDAFEN 100MG-5ML SUSPENSION MEDPHARMA PHARMACEUTICAL & CHEMICAL INDUSTRIES 3 years
Belimumab BENLYSTA GLAXOSMITHKLINE (GSK) annual
Amlodipine amlodipine APM 3 years
Haemophilus type b conjugate vaccines haemophilus type b conjugate vaccines GLAXOSMITHKLINE (GSK) 3 years
Levosalbutamol, salbutamol VENTOLIN GLAXOSMITHKLINE (GSK) 3 years
Fluconazole DURACAN JAMJOOM PHARMACEUTICALS COMPANY 3 years
SALBUTAMOL SALBUTAMED 2MG-5ML SYRUP MEDPHARMA PHARMACEUTICAL & CHEMICAL INDUSTRIES 3 years


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