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
MINOXIDIL HAIRGAIN 5% W-V SOLUTION FOR MEN MEDPHARMA PHARMACEUTICAL & CHEMICAL INDUSTRIES 2 years
MINOXIDIL HAIRGAIN 2% W-V SOLUTION FOR WOMEN MEDPHARMA PHARMACEUTICAL & CHEMICAL INDUSTRIES 2 years
Human Insulin Humulin N Cartridges Eli Lilly 3 years
Human Insulin Humulin N 100 Iuml/ml 10 ml Eli Lilly 3 years
Human Insulin Humulin R 100 IU/ml 10 ml Eli Lilly 3 years
Human Insulin Humulin 70/30 100 IU/ml 10 ml Eli Lilly 3 years
Human Insulin Humulin R Cartrides Eli Lilly 3 years
Human Insulin Humulin 70/30 Cartridges Eli Lilly 3 years
Daratumumab DARZALEX JANSSEN-CILAG 6 months
Diphtheria / tetanus / pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin) (acellular, component) / hepatitis b (rdna) / poliomyelitis (inactivated) / haemophilus type b conjugate vaccines (adsorbed) INFANRIX GLAXOSMITHKLINE (GSK) 3 years


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