Periodic safety reporting schedule

Share page

Active Substances Trade Name MAH Year of registration in Saudi Arabia International Birth Date (IBD) PSUR Submission Frequency Data Lock Point (DLP) Submission Date
TELITHROMYCIN KETEK SANOFI PASTEUR 3 years
DARIFENACIN HYDROBROMIDE ENABLEX ASPEN 3 years
RIBAVIRIN Copegus ROCHE 3 years
EXCHLORPHENIRAMINE MALEATE (+) PSEUDOEPHEDRINE SULFATE (+) GUAIFENESI POLARAMINE MERCK SHARP & DOHME 3 years
Carbimazol NEO-MERCAZOLE AMDIPHARMA 3 years
Carfilzomib Kyprolis AMGEN 6 months
Grazoprevir / elbasvir Zepatier MERCK SHARP & DOHME 6 Months
Ibuprofen ,Pseudoephedrine ADVIL PFIZER annual
Peginterferon beta-1a Plegridy Algorithm annual
Evolocumab Repatha AMGEN 6 months


هل استفدت من ما هو مقدم في هذه الصفحة؟
0 من الزوار ردوا بنعم من أصل0 مشاركة
السبب
السبب