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 |
---|---|---|---|---|---|---|---|
Acetylsalicylic acid | REMIN | APM | 3 years | ||||
Gabapentin | NEURONTIN | PFIZER | 3 Years | ||||
Mesterolone | Proviron | BAYER PHARMA AG | 3 years | ||||
Glipizide | MINIDIAB | PFIZER | 3 Years | ||||
Pegfilgrastim | Neulastim | AMGEN | 3 years | ||||
INTERFERON GAMMA-1b | Imukin | BOEHRINGER INGELHEIM | 3 years | ||||
LEVOTHYROXINE | ELTROXIN | ASPEN | 3 years | ||||
Amlodipine Besilate, Atorvastatin Calcium | CADUET | PFIZER | 3 Years | ||||
ETOPOSIDE | ETOPOSID "EBEWE" | SANDOZ | 2 Years | ||||
Carboplatin | Carboplatin | PFIZER | 3 Years |