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
IPRATROPIUM BROMIDE Atrovent BOEHRINGER INGELHEIM 3 years
Omega-3-acid Ethyl Esters OMACOR ABBOTT Laboratories 3 years
Fampridine Fampyra Algorithm 3 years
Amisulpride SOLIAN SANOFI PASTEUR 3 years
Meningococcal Conjugate vaccine Menactra SANOFI PASTEUR 3 years
Pneumococcal Polysacchride Conjugate Vaccine, 13 Valent PREVENAR 13 PFIZER 3 years
Adalimumab HUMIRA ABBVIE 3 years
Repaglinide NovoNorm 0.5mg NOVO NORDISK 3 years
Repaglinide NovoNorm 2mg NOVO NORDISK 3 years
Repaglinide NovoNorm 1mg NOVO NORDISK 3 years


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