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 |
---|---|---|---|---|---|---|---|
BUDESONIDE, FORMOTEROL | SYMBICORT | AstraZeneca | 3 years | ||||
Infliximab | REMICADE | JANSSEN-CILAG | 3 years | ||||
Paricalcitol | ZEMPLAR | ABBVIE | 3 years | ||||
Oxcarbazepine | Trileptal | NOVARTIS | 2 years | ||||
Telbivudine | Sebivo | NOVARTIS | 3 years | ||||
Catridecacog | NovoThirteen 2500 IU | NOVO NORDISK | 3 years | ||||
Agalsidase Beta | Fabrazyme | SANOFI PASTEUR | 3 years | ||||
Meloxicam | MELOXI | JAMJOOM PHARMACEUTICALS COMPANY | 3 years | ||||
MELOXICAM | Mobic | BOEHRINGER INGELHEIM | 3 years | ||||
Meloxicam | meloxicam | APM | 3 years |