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 |
|---|---|---|---|---|---|---|---|
| Rocuronium | RUCORON |
Jazeera Pharmaceutical Industries (JPI) | 2017 | 3 years | 2019-02-28 | 2019-05-29 | |
| Cinacalcet | Mimpara |
AMGEN | 2008 | 2004-03-08 | 3 years | 2019-02-28 | 2019-05-29 |
| Desvenlafaxine Succinate | PRISTIQ |
PFIZER | 2011 | 2008-02-29 | 3 Years | 2019-02-28 | 2019-05-29 |
| Zinc chloride, Copper chloride dihydrate, Manganese chloride tetrahydrate, Sodium selenite pentahydrate, Sodium fluoride, Potassium iodide |
Peditrace |
FRESENIUS KABI | 1989 | 1993-02-05 | 3 years | 2019-02-28 | 2019-05-28 |
| Degarelix | Firmagon |
FERRING | 2010 | 2008-12-24 | 3 years | 2019-02-17 | 2019-05-18 |
| Dorzolamide | XOLA |
JAMJOOM PHARMACEUTICALS COMPANY | 1998 | 1994-11-11 | 3 years | 2019-02-18 | 2019-05-17 |
| Dorzolamide / timolol | XOLAMOL |
JAMJOOM PHARMACEUTICALS COMPANY | 2001 | 1998-06-03 | 3 years | 2019-02-18 | 2019-05-17 |
| Pimozide | ORAP FORTE |
JANSSEN-CILAG | 1981 | 1968-10-01 | 3 years | 2019-02-15 | 2019-05-16 |
| Acetylsalicylic acid | REMIN |
APM | 2003 | 1942-10-17 | 3 years | 2019-02-01 | 2019-05-02 |
| Gabapentin | NEURONTIN |
PFIZER | 1997 | 1993-02-05 | 3 Years | 2019-02-01 | 2019-05-02 |