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 |
|---|---|---|---|---|---|---|---|
| Afatinib | Giotrif | BOEHRINGER INGELHEIM | annual | ||||
| Etonogestrel implant- implanon | IMPLANON NXT | MERCK SHARP & DOHME | 3 years | ||||
| Lacosamide | Vimpat | U.C.B | 3 years | ||||
| Meropenem | MEPRA | Jazeera Pharmaceutical Industries (JPI) | 3 years | ||||
| Dabigatran | PRADAXA | BOEHRINGER INGELHEIM | annual | ||||
| Ceftolozane / Tazobactam | Zerbaxa | MERCK SHARP & DOHME | 6 months | ||||
| Moroctocog Alfa | XYNTHA | PFIZER | 2 Years | ||||
| ACETYLCYSTEINE | ACC LONG 600MG EFFERVESCENT TABLETS | SANDOZ | 3 Years | ||||
| ACETYLCYSTEINE | ACC 200MG POWDER FOR ORAL SOLUTION | SANDOZ | 3 Years | ||||
| Granisetron | SANCUSO 34.3 mg transdermal patch | ProStrakan Inc | annual |
