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 |
---|---|---|---|---|---|---|---|
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 |