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 |
---|---|---|---|---|---|---|---|
Palivizumab | SYNAGIS | ABBVIE | 3 year | ||||
BUPRENOPHINE |
BUTRANS | NAPP PHARMACEUTICALS LIMITED | 3 years | ||||
Spironolactone | ALDACTONE | PFIZER | 3 Years | ||||
Tigecycline | TYGACIL | PFIZER | 3 Years | ||||
Octreotide | Sandostatin LAR | NOVARTIS | 3 years | ||||
Octreotide | Sandostatin | NOVARTIS | 3 years | ||||
Oxytocin | Syntocinon | NOVARTIS | 3 years | ||||
METHOTREXATE | METHOTREXATE "EBEWE | SANDOZ | 3 Years | ||||
TETRACOSACTIDE | SYNACTHEN DEPOT | MALLINCKRODT SPECIALTY PHARMACEUTICALS | 3 years | ||||
Varenicline Tartrate | CHAMPIX | PFIZER | 3 Years |