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 |
|---|---|---|---|---|---|---|---|
| Ondansetron | ondansetron |
APM | 1970 | 3 years | 2018-02-28 | 2018-05-29 | |
| Hepatitis b vaccine (rdna) | ENGERIX |
GLAXOSMITHKLINE (GSK) | 1995 | 1986-11-14 | 2 years | 2018-02-28 | 2018-05-29 |
| Hepatitis b vaccine (recombinant) | Recombivax HB |
MERCK SHARP & DOHME | 1995 | 1986-11-14 | 2 years | 2018-02-28 | 2018-05-29 |
| Ondansetron (Injection) | DANSETRON |
Hikma Pharmaceuticals PLC | 2006 | 3 years | 2018-02-28 | 2018-05-29 | |
| Ampicillin Sodium, Sulbactam Sodium | UNASYN |
PFIZER | 1993 | 1983-11-29 | 3 Years | 2018-02-28 | 2018-05-29 |
| Galantamine Hydrobromide | REMINYL |
JANSSEN-CILAG | 2004 | 2000-03-01 | 3 years | 2018-02-28 | 2018-05-29 |
| Influenza vaccine | INFLUVAC |
ABBOTT Laboratories | 1996 | annual | 2018-03-15 | 2018-05-24 | |
| Influenza vaccine | Vaxigrip |
SANOFI PASTEUR | 1994 | 2001-04-06 | annual | 2018-03-15 | 2018-05-24 |
| Dexmedetomidine Hydrochloride | PRECEDEX |
PFIZER | 2002 | 1999-12-17 | annual | 2018-03-15 | 2018-05-24 |
| Lapatinib | Tyverb |
NOVARTIS | 2013 | 2007-03-13 | annual | 2018-03-12 | 2018-05-21 |