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 |
|---|---|---|---|---|---|---|---|
| Topiramate | TOPAMAX |
JANSSEN-CILAG | 1999 | 1995-07-18 | 3 years | 2018-01-18 | 2018-04-18 |
| Etanercept | ENBREL |
PFIZER | 2007 | 1998-11-02 | annual | 2018-02-02 | 2018-04-13 |
| Gemcitabine | Gemzar 200 mg |
Eli Lilly | 1999 | 1995-01-12 | 3 years | 2018-01-12 | 2018-04-12 |
| Nilotinib hydrochloride monohydrate | Tasigna Capsule 200 mg |
NOVARTIS | 2008 | 2007-07-24 | annual | 2018-01-31 | 2018-04-11 |
| Pregabalin | LYRICA |
PFIZER | 2006 | 2004-07-06 | annual | 2018-01-31 | 2018-04-11 |
| DEXAMETHASONE, HYPROMELLOSE | MAXIDEX DROPS 0.1% |
ALCON | 1982 | 1952-01-01 | annual | 2018-01-31 | 2018-04-10 |
| NEOMYCIN SULPHATE, POLYMYXIN B SULPHATE, DEXAMETHASONE | MAXITROL DROPS |
ALCON | 1981 | 1952-01-01 | annual | 2018-01-31 | 2018-04-10 |
| NEOMYCIN SULPHATE, POLYMYXIN B SULPHATE, DEXAMETHASONE | MAXITROL EYE OINT. |
ALCON | 1994 | 1952-01-01 | annual | 2018-01-31 | 2018-04-10 |
| Axitinib | INLYTA |
PFIZER | 2015 | 2012-01-27 | annual | 2018-01-26 | 2018-04-06 |
| Furosemide | DIUSEMIDE |
APM | 1982 | 1955-01-01 | 3 years | 2018-01-01 | 2018-04-01 |