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 |
|---|---|---|---|---|---|---|---|
| Human normal Immunoglobulins | Flebogamma | INSTITUTO GRIFOLS | annual | ||||
| EMEDASTINE | EMADINE 0.05% EYE DROPS | ALCON | 3 Years | ||||
| Human normal Immunoglobulins | Gamunex | INSTITUTO GRIFOLS | annual | ||||
| Elotuzumab | Empliciti | BRISTOL-MYERS SQUIBB | 6 months | ||||
| NEVIRAPINE | Viramune | BOEHRINGER INGELHEIM | 3 years | ||||
| CEFTRIAXONE | MEGION IV | SANDOZ | 3 Years | ||||
| Fidaxomicin | DIFICLIR | ASTELLAS PHARMA | annual | ||||
| Measles, mumps, and rubella (wistar ra 27-3) virus vacc, live | M-M-R II | MERCK SHARP & DOHME | 3 year | ||||
| Measles / mumps / rubella vaccines (live, attenuated) | PRIORIX | GLAXOSMITHKLINE (GSK) | 3 years | ||||
| Interferon beta-1a | Avonex | Algorithm | 3 years |
