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 |
---|---|---|---|---|---|---|---|
Cabergoline | DOSTINEX | PFIZER | 3 Years | ||||
Sildenafil Citrate | VIAGRA | PFIZER | 3 Years | ||||
Canagliflozin | INVOKANA | JANSSEN-CILAG | Annual | ||||
Bimatoprost | Lumigan Eye Drops | Allergan | 3 Years | ||||
OCRELIZUMAB | Ocrevus | ROCHE | 6 months | ||||
Meningococcal group a, c, w135, y polysaccharide vaccine | Menveo | GLAXOSMITHKLINE (GSK) | 3 years | ||||
Ipilimumab | Yervoy | BRISTOL-MYERS SQUIBB | annual | ||||
hydroxyethyl starch 6% (HES 130/0.4) in normal saline solution | Voluven 6% IV infusion | FRESENIUS KABI | Annual | ||||
Dobutamine Hydrochloride | Dobutamine Hydrochloride | PFIZER | 3 Years | ||||
Dobutamine | DOBUTAMINE | Jazeera Pharmaceutical Industries (JPI) | 3 years |