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