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 |
|---|---|---|---|---|---|---|---|
| Ranitidine | ZYDAC | JAMJOOM PHARMACEUTICALS COMPANY | 3 years | ||||
| Ketoconazole | NIZORAL | JANSSEN-CILAG | 3 years | ||||
| Risperidone | RISPERDAL | JANSSEN-CILAG | 3 years | ||||
| Flunarizine Hydrochloride | SIBELIUM | JANSSEN-CILAG | 3 years | ||||
| Ranitidine (HCl) | NADINE | Pharma International Co | 3 years | ||||
| Piroxicam | Piroxicam | PFIZER | 3 Years | ||||
| Ranitidine | ROLAN | Hikma Pharmaceuticals PLC | 3 years | ||||
| Ranitidine | Glotac | SANOFI PASTEUR | 3 years | ||||
| Imiglucerase | Cerezyme | SANOFI PASTEUR | 3 years | ||||
| Paracetamol | TYLENOL | JANSSEN-CILAG | 3 years |
