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 |
---|---|---|---|---|---|---|---|
Methotrexate | Methotrexate | PFIZER | 3 Years | ||||
9-2- | XALACOM | PFIZER | 3 Years | ||||
CANDESARTAN CILEXETIL | DICERAN | SANDOZ | 2 Years | ||||
Rabeprazole Sodium | PARIET | JANSSEN-CILAG | 3 years | ||||
Sufentanil Citrate | SUFENTA | JANSSEN-CILAG | 3 years | ||||
DESFLURANE | SUPRANE INHALATION ANAESTHITIC - 240mL | Baxter | 3 years | ||||
Vigabatrin | Sabril | SANOFI PASTEUR | 3 years | ||||
Leflunomide | Arava | SANOFI PASTEUR | 3 years | ||||
Sirolimus | RAPAMUNE | PFIZER | 3 Years | ||||
Diphtheria, Tetanus Toxoids, Acellular Pertussis & Haemophilus b Conjugate Vaccine |
Actacel | SANOFI PASTEUR | 3 years |