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 |
|---|---|---|---|---|---|---|---|
| Carbetocin | PABAL® RTS 100mcg/ ml Solution for Injection | Ferring GmbH/Germany | 2008 | 1997-01-24 | 5 years | 2027-06-30 | 2027-09-28 |
| Carbetocin | PABAL® RTS 100mcg/ ml Solution for Injection | Ferring GmbH/Germany | 2008 | 1997-01-24 | 5 years | 2027-06-30 | 2027-09-28 |
| Terlipressin | Glypressin 0.1mg/ml Solution For Injection |
Ferring GmbH/Germany | 2014 | 1980-05-01 | 3 years | 2024-04-30 | 2024-07-29 |
| Terlipressin | Glypressin 0.1mg/ml Solution For Injection |
Ferring GmbH/Germany | 2014 | 1980-05-01 | 3 years | 2024-04-30 | 2024-07-29 |
| Abaloparatide | Tymlos | "Labatec Pharma SA, Switzerland" | 2024 | 2017-04-28 | Annually | 2024-04-26 | 2024-07-24 |
| Abaloparatide | Tymlos | "Labatec Pharma SA, Switzerland" | 2024 | 2017-04-28 | Annually | 2024-04-26 | 2024-07-24 |
| Mesalazine | PENTASA 4g Sachet Prolonged Release Granules | Ferring GmbH/Germany | 2020 | 1986-08-28 | 2 years | 2024-02-19 | 2024-05-19 |
| Mesalazine | PENTASA 4g Sachet Prolonged Release Granules | Ferring GmbH/Germany | 2020 | 1986-08-28 | 2 years | 2024-02-19 | 2024-05-19 |
| Mesalazine | Pentasa 500mg Tablet | Ferring GmbH/Germany | 2007 | 1986-08-28 | 2 years | 2024-02-19 | 2024-05-19 |
| Mesalazine | Pentasa 500mg Tablet | Ferring GmbH/Germany | 2007 | 1986-08-28 | 2 years | 2024-02-19 | 2024-05-19 |