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 |
---|---|---|---|---|---|---|---|
SAXAGLIPTIN | ONGLYZA | AstraZeneca | 3 years | ||||
Ibuprofen (indicated in ductus arteriosus) | JAZOFEN | Jazeera Pharmaceutical Industries (JPI) | 3 years | ||||
Ibuprofen (indicated in ductus arteriosus) | BALKAPROFEN | APM | 3 years | ||||
Ibuprofen | NUFEN | Hikma Pharmaceuticals PLC | 3 years | ||||
Ribavirin | ribavirin | APM | 3 years | ||||
Natalizumab | Tysabri | Algorithm | annual | ||||
Idursulfase | Elaprase | Algorithm | annual | ||||
Epirubicin | EPIRUBICIN JAZEERA | Jazeera Pharmaceutical Industries (JPI) | 3 years | ||||
METHOTREXATE | METHOTREXATE | SANOFI PASTEUR | 3 years | ||||
Oxytocin | GYNOCIN | Jazeera Pharmaceutical Industries (JPI) | 3 years |