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 |
|---|---|---|---|---|---|---|---|
| Tacrolimus | PROGRAF |
Hikma Pharmaceuticals PLC | 2000 | 1993-02-04 | 3 years | 2018-03-31 | 2018-06-29 |
| Somatropin | Norditropin NordiLet 10mg |
NOVO NORDISK | 2004 | 2008-03-31 | 3 years | 2018-03-31 | 2018-06-29 |
| Somatropin | Norditropin NordiLet 15mg |
NOVO NORDISK | 2004 | 2008-03-31 | 3 years | 2018-03-31 | 2018-06-29 |
| Somatropin | Norditropin NordiLet 5mg |
NOVO NORDISK | 2004 | 2008-03-31 | 3 years | 2018-03-31 | 2018-06-29 |
| Somatropin | Norditropin SimpleXx 5 mg |
NOVO NORDISK | 2004 | 2008-03-31 | 3 years | 2018-03-31 | 2018-06-29 |
| Somatropin | Norditropin SimpleXx 10 mg |
NOVO NORDISK | 2004 | 2008-03-31 | 3 years | 2018-03-31 | 2018-06-29 |
| Somatropin | Norditropin SimpleXx 15 mg |
NOVO NORDISK | 2004 | 2008-03-31 | 3 years | 2018-03-31 | 2018-06-29 |
| Temsirolimus | TORISEL |
PFIZER | 2012 | 2007-05-30 | 3 Years | 2018-03-31 | 2018-06-29 |
| Itraconazole | SPORANOX |
JANSSEN-CILAG | 1992 | 1987-08-31 | 3 years | 2018-03-31 | 2018-06-29 |
| Acarbose | Glucobay |
BAYER PHARMA AG | 1996 | 1990-03-31 | 3 years | 2018-03-31 | 2018-06-29 |