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 |
|---|---|---|---|---|---|---|---|
| Galantamine Hydrobromide | REMINYL | JANSSEN-CILAG | 3 years | ||||
| Ampicillin Sodium, Sulbactam Sodium | UNASYN | PFIZER | 3 Years | ||||
| Hepatitis b vaccine (recombinant) | Recombivax HB | MERCK SHARP & DOHME | 2 years | ||||
| Ondansetron (Injection) | DANSETRON | Hikma Pharmaceuticals PLC | 3 years | ||||
| Ondansetron | ondansetron | APM | 3 years | ||||
| Hepatitis b vaccine (rdna) | ENGERIX | GLAXOSMITHKLINE (GSK) | 2 years | ||||
| Influenza vaccine | INFLUVAC | ABBOTT Laboratories | annual | ||||
| Dexmedetomidine Hydrochloride | PRECEDEX | PFIZER | annual | ||||
| Influenza vaccine | Vaxigrip | SANOFI PASTEUR | annual | ||||
| Lapatinib | Tyverb | NOVARTIS | annual |
