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 |
---|---|---|---|---|---|---|---|
Memantine | MEMAXIA | JAMJOOM PHARMACEUTICALS COMPANY | 3 years | ||||
Filgrastim | Neupogen | AMGEN | 3 years | ||||
Alfentanil Hydrochloride | RAPIFEN | JANSSEN-CILAG | 3 years | ||||
Teriparatide (PTH ) | Forteo | Eli Lilly | 3 years | ||||
Diclofenac sodium | Voltaren Suppository | NOVARTIS | 3 years | ||||
Diclofenac potassium | Voltfast Powder for oral solution | NOVARTIS | 3 years | ||||
Eltrombopag | Revolade | NOVARTIS | annual | ||||
Baclofen | Lioresal | NOVARTIS | 2 years | ||||
Diclofenac potassium | Cataflam | NOVARTIS | 3 years | ||||
Hydrochlorothiazide | Rasilez HCT | NOVARTIS | annual |