Periodic safety reporting schedule
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 |