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 |
---|---|---|---|---|---|---|---|
Insulin aspart | NovoMix 70 FlexPen | NOVO NORDISK | 3 years | ||||
Diclofenac potassium | DOLVIC- K | Pharma International Co | 3 years | ||||
Insulin aspart | NovoMix 30 FlexPen | NOVO NORDISK | 3 years | ||||
Diclofenac Sodium | FAST- FLAM , VOLTIC | JAMJOOM PHARMACEUTICALS COMPANY | 3 years | ||||
Insulin aspart | NovoMix 50 Penfill | NOVO NORDISK | 3 years | ||||
Diclofenac Epolamin | FLECTOR EP TISSUGEL 1GM PATCHES | IBSA INSTITUTE BIOCHIMIQUE S.A | 3 years | ||||
Diclofenac (topical formulations) | DICLOMAX | Jazeera Pharmaceutical Industries (JPI) | 3 years | ||||
Diclofenac (systemic ) | INFLA-BAN | APM | 3 years | ||||
Diclofenac sodium | Flector tissugel | IBSA INSTITUTE BIOCHIMIQUE S.A | 3 years | ||||
Diclofenac (systemic formulations) | DICLOMAX | Jazeera Pharmaceutical Industries (JPI) | 3 years |