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 |
---|---|---|---|---|---|---|---|
TESTOSTERONE | SUSTANON | MERCK SHARP & DOHME | 3 years | ||||
Roxithromycin | Rulid | SANOFI PASTEUR | 3 years | ||||
Botulinum Toxin 100 U | Botox 100 U | Allergan | 3 Year | ||||
Thyme Liquid Extract + primula root Liquid extract | Bronchicum Elixir | SANOFI PASTEUR | 3 years | ||||
PRIMULA FLUID EXTRACT + THYME LIQUID EXTRACT | BRONCHICUM ELIXIR | SANOFI PASTEUR | 3 years | ||||
Oxaliplatin | Oxaliplatin | PFIZER | 3 Years | ||||
Entacapone | Comtan | NOVARTIS | 3 years | ||||
Darunavir | PREZISTA | JANSSEN-CILAG | 3 years | ||||
Valaciclovir | VALTREX | GLAXOSMITHKLINE (GSK) | 3 years | ||||
CEFOTAXIME SODIUM | CLAFORAN | SANOFI PASTEUR | 3 years |