Periodic safety reporting schedule
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 | Gamunex |
INSTITUTO GRIFOLS | 2017 | 2003-08-11 | annual | 2018-05-31 | 2018-08-09 |
| Human normal Immunoglobulins | Flebogamma |
INSTITUTO GRIFOLS | 2009 | 1992-11-30 | annual | 2018-05-31 | 2018-08-09 |
| Human normal Immunoglobulins | Flebogamma DIF |
INSTITUTO GRIFOLS | 2017 | 2006-12-21 | annual | 2018-05-31 | 2018-08-09 |
| Elotuzumab | Empliciti |
BRISTOL-MYERS SQUIBB | 2017 | 2015-11-30 | 6 months | 2017-05-29 | 2018-08-07 |
| CEFTRIAXONE | MEGION IV |
SANDOZ | 2007 | 3 Years | 2018-05-26 | 2018-08-04 | |
| Fidaxomicin | DIFICLIR |
ASTELLAS PHARMA | 2017 | 2011-05-27 | annual | 2018-05-26 | 2018-08-04 |
| NEVIRAPINE | Viramune |
BOEHRINGER INGELHEIM | 2000 | 1998-02-05 | 3 years | 2018-05-06 | 2018-08-04 |
| Measles, mumps, and rubella (wistar ra 27-3) virus vacc, live | M-M-R II |
MERCK SHARP & DOHME | 2000 | 1997-11-28 | 3 year | 2018-05-04 | 2018-08-02 |
| Measles / mumps / rubella vaccines (live, attenuated) | PRIORIX |
GLAXOSMITHKLINE (GSK) | 2001 | 1997-11-28 | 3 years | 2018-05-04 | 2018-08-02 |
| Interferon beta-1a | Avonex |
Algorithm | 2016 | 1997-03-13 | 3 years | 2018-05-03 | 2018-08-01 |