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 |
|---|---|---|---|---|---|---|---|
| Ofatumumab | Arzerra |
NOVARTIS | 2013 | 2009-10-26 | annual | 2018-10-25 | 2019-01-03 |
| Pasireotide | Signifor |
NOVARTIS | 2015 | 2012-04-29 | annual | 2018-10-24 | 2019-01-02 |
| Metoclopramide | CLOPRAM |
Jazeera Pharmaceutical Industries (JPI) | 2016 | 1966-10-03 | 3 years | 2018-10-03 | 2019-01-01 |
| Metoclopramide | PRIMPERAN 10mg |
SANOFI PASTEUR | 1982 | 1964-11-17 | 3 years | 2018-10-03 | 2019-01-01 |
| Levofloxacin | LEVONIC |
Jazeera Pharmaceutical Industries (JPI) | 2012 | 1993-01-10 | 3 years | 2018-10-01 | 2018-12-30 |
| Levofloxacin | Tavanic |
SANOFI PASTEUR | 2003 | 1993-10-01 | 3 years | 2018-10-01 | 2018-12-30 |
| Levofloxacin | NEVOTIC |
Pharma International Co | 2017 | 1993-01-10 | 3 years | 2018-10-01 | 2018-12-30 |
| Diclofenac (systemic ) | INFLA-BAN |
APM | 1993 | 1977-11-05 | 3 years | 2018-09-30 | 2018-12-29 |
| Diclofenac (topical ) | INFLA-BAN |
APM | 1994 | 1977-11-05 | 3 years | 2018-09-30 | 2018-12-29 |
| Diclofenac Sodium | FAST- FLAM , VOLTIC |
JAMJOOM PHARMACEUTICALS COMPANY | 1980 | 1977-11-05 | 3 years | 2018-09-30 | 2018-12-29 |