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
Allopurinol PURINOL Hikma Pharmaceuticals PLC annual
Dienogest Visanne BAYER PHARMA AG 3 years
Pneumococcal polysaccharide conjugate vaccine (adsorbed) - 10 valent SYNFLORIX GLAXOSMITHKLINE (GSK) annual
Calcium salts / colecalciferol calcium salts / colecalciferol GLAXOSMITHKLINE (GSK) 3 years
Human papillomavirus vaccine (rdna) - 2-valent CERVARIX VACCINE GLAXOSMITHKLINE (GSK) annual
Umeclidinium bromide INCRUSE ELLIPTA GLAXOSMITHKLINE (GSK) annual
Ropinirole REQUIP GLAXOSMITHKLINE (GSK) 3 years
Umeclidinium bromide / vilanterol ANORO ELLIPTA GLAXOSMITHKLINE (GSK) 6 months
IFENPRODIL TARTRATE VADILEX SANOFI PASTEUR 3 years
Desmopressin Minirin Tab FERRING 3 years


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