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 |
---|---|---|---|---|---|---|---|
Betahistine | BETASERC | ABBOTT Laboratories | 3 years | ||||
Pseudoephedrine / triprolidine | RINOFED | Jazeera Pharmaceutical Industries (JPI) | 3 years | ||||
Pseudoephedrine / triprolidine | TRIFED | Hikma Pharmaceuticals PLC | 3 years | ||||
Betahistine | BERTIGO | Jazeera Pharmaceutical Industries (JPI) | 3 years | ||||
Pseudoephedrine / triprolidine | COLFED | APM | 3 years | ||||
Azelastine hydrochloride | Allergodil | MEDA PHARMA GmbH & Co KG | 3 years | ||||
Celecoxib | CELEBREX | PFIZER | 3 Years | ||||
Ombitasvir/Paritaprevir/ritonavir | VIEKIRAX | ABBVIE | annual | ||||
Dasabuvir | EXVIERA | ABBVIE | annual | ||||
Levonorgestrel | Microlut 0.03 Mg | BAYER PHARMA AG | 3 years |