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 |
|---|---|---|---|---|---|---|---|
| Acetylsalicylic Acid | Aspirin Protect 100Mg |
BAYER PHARMA AG | 1989 | 1969-02-01 | 3 years | 2019-02-01 | 2019-05-02 |
| Acetylsalicylic Acid | Aspirin Adult 300Mg |
BAYER PHARMA AG | 1989 | 1969-02-01 | 3 years | 2019-02-01 | 2019-05-02 |
| INTERFERON GAMMA-1b | Imukin |
BOEHRINGER INGELHEIM | 1997 | 1992-09-28 | 3 years | 2019-01-31 | 2019-05-01 |
| Pegfilgrastim | Neulastim |
AMGEN | 2007 | 2002-01-31 | 3 years | 2019-01-31 | 2019-05-01 |
| LEVOTHYROXINE | ELTROXIN |
ASPEN | 1996 | 1952-01-01 | 3 years | 2016-01-01 | 2019-05-01 |
| Amlodipine Besilate, Atorvastatin Calcium | CADUET |
PFIZER | 2006 | 2004-01-30 | 3 Years | 2019-01-31 | 2019-05-01 |
| Glipizide | MINIDIAB |
PFIZER | 1983 | 1971-04-29 | 3 Years | 2019-01-31 | 2019-05-01 |
| Mesterolone | Proviron |
BAYER PHARMA AG | 1970 | 1967-05-25 | 3 years | 2019-01-31 | 2019-05-01 |
| ETOPOSIDE | ETOPOSID "EBEWE" |
SANDOZ | 2001 | 2003-06-18 | 2 Years | 2019-02-16 | 2019-04-27 |
| Carboplatin | Carboplatin |
PFIZER | 1997 | 1988-04-13 | 3 Years | 2019-01-23 | 2019-04-23 |