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 |
|---|---|---|---|---|---|---|---|
| Insulin degludec/insulin aspart | Ryzodeg Penfill 100 IU/ml |
NOVO NORDISK | 2017 | 2012-09-28 | 3 years | 2019-09-30 | 2019-12-29 |
| Dinoprostone | PROSTIN |
PFIZER | 1993 | 1972-09-26 | 3 Years | 2019-09-30 | 2019-12-29 |
| Dinoprostone | Propess |
FERRING | 2009 | 1995-03-01 | 3 years | 2019-09-30 | 2019-12-29 |
| Bromhexine | SOLVEX |
Jazeera Pharmaceutical Industries (JPI) | 2000 | 1963-01-07 | 3 years | 2019-09-30 | 2019-12-29 |
| Alglucosidase alfa | Myozyme |
SANOFI PASTEUR | 2018 | 2006-03-29 | 3 years | 2019-09-28 | 2019-12-27 |
| Trabectedin | YONDELIS |
JANSSEN-CILAG | 2014 | 2007-09-17 | 3 years | 2019-09-17 | 2019-12-16 |
| Ranibizumab | Lucentis |
NOVARTIS | 2008 | 2006-06-30 | 3 years | 2019-10-05 | 2019-12-14 |
| Glycopyrronium Bromide | Seebri Breezhaler Inhalation powder |
NOVARTIS | 2016 | 2012-09-28 | 3 years | 2019-09-28 | 2019-12-07 |
| Drospirenone-Ethinylestradiol | Yasmin |
BAYER PHARMA AG | 2001 | 2000-03-07 | 3 years | 2019-09-06 | 2019-12-05 |
| Drospirenone-Ethinylestradiol-Levomefolate calcium | Yaz Plus Film-Coated |
BAYER PHARMA AG | 2016 | 2010-09-24 | 3 years | 2019-09-06 | 2019-12-05 |